New drugs (FDA record)

Every new-molecule drug the FDA approved, by date, at the company that made it. 981 points on the WW9 Atlas, oldest first, each with its source.

Open this layer on the map

Pages: 1 2 3

• Evista (raloxifene hydrochloride)1997 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 1997-12-09. Active ingredient: raloxifene hydrochloride. Sponsor: Lilly. Application NDA020815.FDA Drugs@FDA, application NDA020815 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020815)
• Fareston (toremifene citrate)1997 · FDA new drug approval · Kyowa Kirin headquarters, Otemachi Financial City Grand CubeNew drug approved by the FDA on 1997-05-29. Active ingredient: toremifene citrate. Sponsor: Kyowa Kirin. Application NDA020497.FDA Drugs@FDA, application NDA020497 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020497)
• Flomax (tamsulosin hydrochloride)1997 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 1997-04-15. Active ingredient: tamsulosin hydrochloride. Sponsor: Sanofi. Application NDA020579.FDA Drugs@FDA, application NDA020579 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020579)
• Meridia (sibutramine hydrochloride)1997 · FDA new drug approval · Abbott Laboratories headquarters, North ChicagoNew drug approved by the FDA on 1997-11-22. Active ingredient: sibutramine hydrochloride. Sponsor: Abbott. Application NDA020632.FDA Drugs@FDA, application NDA020632 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020632)
• Mirapex (pramipexole dihydrochloride)1997 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 1997-07-01. Active ingredient: pramipexole dihydrochloride. Sponsor: Boehringer Ingelheim. Application NDA020667.FDA Drugs@FDA, application NDA020667 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020667)
• Omnicef (cefdinir)1997 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 1997-12-04. Active ingredient: cefdinir. Sponsor: Abbvie. Application NDA050739.FDA Drugs@FDA, application NDA050739 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050739)
• Plavix (clopidogrel bisulfate)1997 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 1997-11-17. Active ingredient: clopidogrel bisulfate. Sponsor: Sanofi Aventis Us. Application NDA020839.FDA Drugs@FDA, application NDA020839 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020839)
• Quadramet (samarium sm-153 lexidronam pentasodium)1997 · FDA new drug approval · Lantheus Medical Imaging (United States) headquarters, BillericaNew drug approved by the FDA on 1997-03-28. Active ingredient: samarium sm-153 lexidronam pentasodium. Sponsor: Lantheus Medical. Application NDA020570.FDA Drugs@FDA, application NDA020570 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020570)
• Raxar (grepafloxacin hydrochloride)1997 · FDA new drug approval · Otsuka Pharmaceutical headquarters, ChiyodaNew drug approved by the FDA on 1997-11-06. Active ingredient: grepafloxacin hydrochloride. Sponsor: Otsuka. Application NDA020695.FDA Drugs@FDA, application NDA020695 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020695)
• Regranex (becaplermin)1997 · FDA new drug approval · Smith & Nephew headquarters, LondonNew drug approved by the FDA on 1997-12-16. Active ingredient: becaplermin. Sponsor: Smith And Nephew. Application BLA103691.FDA Drugs@FDA, application BLA103691 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103691)
• Requip (ropinirole hydrochloride)1997 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 1997-09-19. Active ingredient: ropinirole hydrochloride. Sponsor: Glaxosmithkline Llc. Application NDA020658.FDA Drugs@FDA, application NDA020658 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020658)
• Rituxan (rituximab)1997 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 1997-11-26. Active ingredient: rituximab. Sponsor: Genentech. Application BLA103705.FDA Drugs@FDA, application BLA103705 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103705)
• Seroquel (quetiapine fumarate)1997 · FDA new drug approval · Cheplapharm Arzneimittel headquarters, GreifswaldNew drug approved by the FDA on 1997-09-26. Active ingredient: quetiapine fumarate. Sponsor: Cheplapharm. Application NDA020639.FDA Drugs@FDA, application NDA020639 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020639)
• Skelid (tiludronate disodium)1997 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 1997-03-07. Active ingredient: tiludronate disodium. Sponsor: Sanofi Aventis Us. Application NDA020707.FDA Drugs@FDA, application NDA020707 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020707)
• Teslascan (mangafodipir trisodium)1997 · FDA new drug approval · IC Targets (Norway) headquarters, OsloNew drug approved by the FDA on 1997-11-26. Active ingredient: mangafodipir trisodium. Sponsor: Ic Targets. Application NDA020652.FDA Drugs@FDA, application NDA020652 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020652)
• Teveten (eprosartan mesylate)1997 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 1997-12-22. Active ingredient: eprosartan mesylate. Sponsor: Abbvie. Application NDA020738.FDA Drugs@FDA, application NDA020738 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020738)
• Trovan (trovafloxacin mesylate)1997 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 1997-12-18. Active ingredient: trovafloxacin mesylate. Sponsor: Pfizer. Application NDA020759.FDA Drugs@FDA, application NDA020759 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020759)
• Trovan Preservative Free (alatrofloxacin mesylate)1997 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 1997-12-18. Active ingredient: alatrofloxacin mesylate. Sponsor: Pfizer. Application NDA020760.FDA Drugs@FDA, application NDA020760 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020760)
• Aggrastat (tirofiban hydrochloride)1998 · FDA new drug approval · Medicure (Canada) headquarters, WinnipegNew drug approved by the FDA on 1998-05-14. Active ingredient: tirofiban hydrochloride. Sponsor: Medicure. Application NDA020912.FDA Drugs@FDA, application NDA020912 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020912)
• Alrex (loteprednol etabonate)1998 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 1998-03-09. Active ingredient: loteprednol etabonate. Sponsor: Bausch And Lomb. Application NDA020803.FDA Drugs@FDA, application NDA020803 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020803)
• Amerge (naratriptan hydrochloride)1998 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 1998-02-10. Active ingredient: naratriptan hydrochloride. Sponsor: Glaxosmithkline Llc. Application NDA020763.FDA Drugs@FDA, application NDA020763 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020763)
• Arava (leflunomide)1998 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 1998-09-10. Active ingredient: leflunomide. Sponsor: Sanofi Aventis Us. Application NDA020905.FDA Drugs@FDA, application NDA020905 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020905)
• Azopt (brinzolamide)1998 · FDA new drug approval · Sandoz headquarters, BaselNew drug approved by the FDA on 1998-04-01. Active ingredient: brinzolamide. Sponsor: Sandoz. Application NDA020816.FDA Drugs@FDA, application NDA020816 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020816)
• Celebrex (celecoxib)1998 · FDA new drug approval · Upjohn headquarters, MichiganNew drug approved by the FDA on 1998-12-31. Active ingredient: celecoxib. Sponsor: Upjohn. Application NDA020998.FDA Drugs@FDA, application NDA020998 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020998)
• Celexa (citalopram hydrobromide)1998 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 1998-07-17. Active ingredient: citalopram hydrobromide. Sponsor: Abbvie. Application NDA020822.FDA Drugs@FDA, application NDA020822 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020822)
• Detrol (tolterodine tartrate)1998 · FDA new drug approval · Upjohn headquarters, MichiganNew drug approved by the FDA on 1998-03-25. Active ingredient: tolterodine tartrate. Sponsor: Upjohn. Application NDA020771.FDA Drugs@FDA, application NDA020771 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020771)
• Enbrel (etanercept)1998 · FDA new drug approval · ImmuneXcite (United States) headquarters, LexingtonNew drug approved by the FDA on 1998-11-02. Active ingredient: etanercept. Sponsor: Immunex. Application BLA103795.FDA Drugs@FDA, application BLA103795 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103795)
• Herceptin (trastuzumab)1998 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 1998-09-25. Active ingredient: trastuzumab. Sponsor: Genentech. Application BLA103792.FDA Drugs@FDA, application BLA103792 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103792)
• Lotemax (loteprednol etabonate)1998 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 1998-03-09. Active ingredient: loteprednol etabonate. Sponsor: Bausch And Lomb. Application NDA020583.FDA Drugs@FDA, application NDA020583 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020583)
• Maxalt (rizatriptan benzoate)1998 · FDA new drug approval · Organon & Co. headquarters, OssNew drug approved by the FDA on 1998-06-29. Active ingredient: rizatriptan benzoate. Sponsor: Organon Llc. Application NDA020864.FDA Drugs@FDA, application NDA020864 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020864)
• Micardis (telmisartan)1998 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 1998-11-10. Active ingredient: telmisartan. Sponsor: Boehringer Ingelheim. Application NDA020850.FDA Drugs@FDA, application NDA020850 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020850)
• Priftin (rifapentine)1998 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 1998-06-22. Active ingredient: rifapentine. Sponsor: Sanofi Aventis Us. Application NDA021024.FDA Drugs@FDA, application NDA021024 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021024)
• Remicade (infliximab)1998 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 1998-08-24. Active ingredient: infliximab. Sponsor: Centocor Inc. Application BLA103772.FDA Drugs@FDA, application BLA103772 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103772)
• Renagel (sevelamer hydrochloride)1998 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 1998-10-30. Active ingredient: sevelamer hydrochloride. Sponsor: Genzyme. Application NDA020926.FDA Drugs@FDA, application NDA020926 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020926)
• Simulect (basiliximab)1998 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 1998-05-12. Active ingredient: basiliximab. Sponsor: Novartis. Application BLA103764.FDA Drugs@FDA, application BLA103764 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103764)
• Singulair (montelukast sodium)1998 · FDA new drug approval · Organon & Co. headquarters, OssNew drug approved by the FDA on 1998-02-20. Active ingredient: montelukast sodium. Sponsor: Organon. Application NDA020829.FDA Drugs@FDA, application NDA020829 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020829)
• Sustiva (efavirenz)1998 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 1998-09-17. Active ingredient: efavirenz. Sponsor: Bristol Myers Squibb. Application NDA020972.FDA Drugs@FDA, application NDA020972 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020972)
• Synagis (palivizumab)1998 · FDA new drug approval · Swedish Orphan Biovitrum headquarters, StockholmNew drug approved by the FDA on 1998-06-19. Active ingredient: palivizumab. Sponsor: Swedish Orphan. Application BLA103770.FDA Drugs@FDA, application BLA103770 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103770)
• Tasmar (tolcapone)1998 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 1998-01-29. Active ingredient: tolcapone. Sponsor: Bausch. Application NDA020697.FDA Drugs@FDA, application NDA020697 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020697)
• Thalomid (thalidomide)1998 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 1998-07-16. Active ingredient: thalidomide. Sponsor: Bristol-Myers. Application NDA020785.FDA Drugs@FDA, application NDA020785 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020785)
• Thyrogen (thyrotropin alfa)1998 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 1998-11-30. Active ingredient: thyrotropin alfa. Sponsor: Genzyme. Application BLA020898.FDA Drugs@FDA, application BLA020898 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020898)
• Viagra (sildenafil citrate)1998 · FDA new drug approval · Viatris headquarters, PittsburghNew drug approved by the FDA on 1998-03-27. Active ingredient: sildenafil citrate. Sponsor: Viatris. Application NDA020895.FDA Drugs@FDA, application NDA020895 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020895)
• Vitravene Preservative Free (fomivirsen sodium)1998 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 1998-08-26. Active ingredient: fomivirsen sodium. Sponsor: Novartis. Application NDA020961.FDA Drugs@FDA, application NDA020961 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020961)
• Xeloda (capecitabine)1998 · FDA new drug approval · Cheplapharm Arzneimittel headquarters, GreifswaldNew drug approved by the FDA on 1998-04-30. Active ingredient: capecitabine. Sponsor: Cheplapharm. Application NDA020896.FDA Drugs@FDA, application NDA020896 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020896)
• Zemplar (paricalcitol)1998 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 1998-04-17. Active ingredient: paricalcitol. Sponsor: Abbvie. Application NDA020819.FDA Drugs@FDA, application NDA020819 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020819)
• Agenerase (amprenavir)1999 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 1999-04-15. Active ingredient: amprenavir. Sponsor: Glaxosmithkline. Application NDA021007.FDA Drugs@FDA, application NDA021007 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021007)
• Aromasin (exemestane)1999 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 1999-10-21. Active ingredient: exemestane. Sponsor: Pfizer. Application NDA020753.FDA Drugs@FDA, application NDA020753 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020753)
• Curosurf (poractant alfa)1999 · FDA new drug approval · Chiesi Farmaceutici S.p.A. headquarters, ParmaNew drug approved by the FDA on 1999-11-18. Active ingredient: poractant alfa. Sponsor: Chiesi Usa Inc. Application BLA020744.FDA Drugs@FDA, application BLA020744 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020744)
• Ellence (epirubicin hydrochloride)1999 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 1999-09-15. Active ingredient: epirubicin hydrochloride. Sponsor: Pfizer Inc. Application NDA050778.FDA Drugs@FDA, application NDA050778 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050778)
• Ferrlecit (sodium ferric gluconate complex)1999 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 1999-02-18. Active ingredient: sodium ferric gluconate complex. Sponsor: Sanofi Aventis Us. Application NDA020955.FDA Drugs@FDA, application NDA020955 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020955)
• Hectorol (doxercalciferol)1999 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 1999-06-09. Active ingredient: doxercalciferol. Sponsor: Sanofi. Application NDA020862.FDA Drugs@FDA, application NDA020862 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020862)
• Keppra (levetiracetam)1999 · FDA new drug approval · UCB headquarters, Brussels metropolitan areaNew drug approved by the FDA on 1999-11-30. Active ingredient: levetiracetam. Sponsor: Ucb Inc. Application NDA021035.FDA Drugs@FDA, application NDA021035 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021035)
• Ontak (denileukin diftitox)1999 · FDA new drug approval · Eisai headquarters, TokyoNew drug approved by the FDA on 1999-02-05. Active ingredient: denileukin diftitox. Sponsor: Eisai Inc. Application BLA103767.FDA Drugs@FDA, application BLA103767 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103767)
• Pletal (cilostazol)1999 · FDA new drug approval · Otsuka Pharmaceutical headquarters, ChiyodaNew drug approved by the FDA on 1999-01-15. Active ingredient: cilostazol. Sponsor: Otsuka. Application NDA020863.FDA Drugs@FDA, application NDA020863 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020863)
• Precedex (dexmedetomidine hydrochloride)1999 · FDA new drug approval · Hospira headquarters, Lake ForestNew drug approved by the FDA on 1999-12-17. Active ingredient: dexmedetomidine hydrochloride. Sponsor: Hospira. Application NDA021038.FDA Drugs@FDA, application NDA021038 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021038)
• Raplon (rapacuronium bromide)1999 · FDA new drug approval · Organon & Co. headquarters, OssNew drug approved by the FDA on 1999-08-18. Active ingredient: rapacuronium bromide. Sponsor: Organon Usa Inc. Application NDA020984.FDA Drugs@FDA, application NDA020984 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020984)
• Relenza (zanamivir)1999 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 1999-07-26. Active ingredient: zanamivir. Sponsor: Glaxosmithkline. Application NDA021036.FDA Drugs@FDA, application NDA021036 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021036)
• Sonata (zaleplon)1999 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 1999-08-13. Active ingredient: zaleplon. Sponsor: Pfizer. Application NDA020859.FDA Drugs@FDA, application NDA020859 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020859)
• Targretin (bexarotene)1999 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 1999-12-29. Active ingredient: bexarotene. Sponsor: Bausch. Application NDA021055.FDA Drugs@FDA, application NDA021055 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021055)
• Temodar (temozolomide)1999 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 1999-08-11. Active ingredient: temozolomide. Sponsor: Merck Sharp Dohme. Application NDA021029.FDA Drugs@FDA, application NDA021029 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021029)
• Tikosyn (dofetilide)1999 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 1999-10-01. Active ingredient: dofetilide. Sponsor: Pfizer. Application NDA020931.FDA Drugs@FDA, application NDA020931 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020931)
• Vioxx (rofecoxib)1999 · FDA new drug approval · Merck KGaA headquarters, DarmstadtNew drug approved by the FDA on 1999-05-20. Active ingredient: rofecoxib. Sponsor: Merck. Application NDA021042.FDA Drugs@FDA, application NDA021042 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021042)
• Xenical (orlistat)1999 · FDA new drug approval · Cheplapharm Arzneimittel headquarters, GreifswaldNew drug approved by the FDA on 1999-04-23. Active ingredient: orlistat. Sponsor: Cheplapharm. Application NDA020766.FDA Drugs@FDA, application NDA020766 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020766)
• Zaditor (ketotifen fumarate)1999 · FDA new drug approval · Alcon headquarters, GenevaNew drug approved by the FDA on 1999-07-02. Active ingredient: ketotifen fumarate. Sponsor: Alcon Pharma. Application NDA021066.FDA Drugs@FDA, application NDA021066 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021066)
• Abreva (docosanol)2000 · FDA new drug approval · Haleon headquarters, WeybridgeNew drug approved by the FDA on 2000-07-25. Active ingredient: docosanol. Sponsor: Haleon Us Holdings. Application NDA020941.FDA Drugs@FDA, application NDA020941 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020941)
• Angiomax (bivalirudin)2000 · FDA new drug approval · Sandoz headquarters, BaselNew drug approved by the FDA on 2000-12-15. Active ingredient: bivalirudin. Sponsor: Sandoz. Application NDA020873.FDA Drugs@FDA, application NDA020873 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020873)
• Argatroban (argatroban)2000 · FDA new drug approval · Sandoz headquarters, BaselNew drug approved by the FDA on 2000-06-30. Active ingredient: argatroban. Sponsor: Sandoz. Application NDA020883.FDA Drugs@FDA, application NDA020883 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020883)
• Cetrotide (cetrorelix acetate)2000 · FDA new drug approval · Merck KGaA headquarters, DarmstadtNew drug approved by the FDA on 2000-08-11. Active ingredient: cetrorelix acetate. Sponsor: Emd Serono Inc. Application NDA021197.FDA Drugs@FDA, application NDA021197 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021197)
• Exelon (rivastigmine tartrate)2000 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2000-04-21. Active ingredient: rivastigmine tartrate. Sponsor: Novartis. Application NDA020823.FDA Drugs@FDA, application NDA020823 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020823)
• Lantus Solostar (insulin glargine recombinant)2000 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 2000-04-20. Active ingredient: insulin glargine recombinant. Sponsor: Sanofi Aventis Us. Application BLA021081.FDA Drugs@FDA, application BLA021081 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021081)
• Mobic (meloxicam)2000 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 2000-04-13. Active ingredient: meloxicam. Sponsor: Boehringer Ingelheim. Application NDA020938.FDA Drugs@FDA, application NDA020938 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020938)
• Novolog Penfill (insulin aspart recombinant)2000 · FDA new drug approval · Novo headquarters, BagsværdNew drug approved by the FDA on 2000-06-07. Active ingredient: insulin aspart recombinant. Sponsor: Novo Nordisk Inc. Application BLA020986.FDA Drugs@FDA, application BLA020986 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020986)
• Rescula (unoprostone isopropyl)2000 · FDA new drug approval · Sucampo Pharmaceuticals headquarters, RockvilleNew drug approved by the FDA on 2000-08-03. Active ingredient: unoprostone isopropyl. Sponsor: Sucampo Pharma Llc. Application NDA021214.FDA Drugs@FDA, application NDA021214 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021214)
• Starlix (nateglinide)2000 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2000-12-22. Active ingredient: nateglinide. Sponsor: Novartis. Application NDA021204.FDA Drugs@FDA, application NDA021204 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021204)
• Tnkase (tenecteplase)2000 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2000-06-02. Active ingredient: tenecteplase. Sponsor: Genentech. Application BLA103909.FDA Drugs@FDA, application BLA103909 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103909)
• Trileptal (oxcarbazepine)2000 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2000-01-14. Active ingredient: oxcarbazepine. Sponsor: Novartis. Application NDA021014.FDA Drugs@FDA, application NDA021014 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021014)
• Zyvox (linezolid)2000 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2000-04-18. Active ingredient: linezolid. Sponsor: Pfizer. Application NDA021130.FDA Drugs@FDA, application NDA021130 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021130)
• Aranesp (darbepoetin alfa)2001 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2001-09-17. Active ingredient: darbepoetin alfa. Sponsor: Amgen. Application BLA103951.FDA Drugs@FDA, application BLA103951 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103951)
• Cancidas (caspofungin acetate)2001 · FDA new drug approval · Merck KGaA headquarters, DarmstadtNew drug approved by the FDA on 2001-01-26. Active ingredient: caspofungin acetate. Sponsor: Merck. Application NDA021227.FDA Drugs@FDA, application NDA021227 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021227)
• Clarinex (desloratadine)2001 · FDA new drug approval · Organon & Co. headquarters, OssNew drug approved by the FDA on 2001-12-21. Active ingredient: desloratadine. Sponsor: Organon. Application NDA021165.FDA Drugs@FDA, application NDA021165 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021165)
• Elidel (pimecrolimus)2001 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 2001-12-13. Active ingredient: pimecrolimus. Sponsor: Bausch. Application NDA021302.FDA Drugs@FDA, application NDA021302 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021302)
• Foradil (formoterol fumarate)2001 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2001-02-16. Active ingredient: formoterol fumarate. Sponsor: Novartis. Application NDA020831.FDA Drugs@FDA, application NDA020831 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020831)
• Geodon (ziprasidone hydrochloride)2001 · FDA new drug approval · Viatris headquarters, PittsburghNew drug approved by the FDA on 2001-02-05. Active ingredient: ziprasidone hydrochloride. Sponsor: Viatris. Application NDA020825.FDA Drugs@FDA, application NDA020825 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020825)
• Gleevec (imatinib mesylate)2001 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2001-05-10. Active ingredient: imatinib mesylate. Sponsor: Novartis. Application NDA021335.FDA Drugs@FDA, application NDA021335 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021335)
• Lemtrada (alemtuzumab)2001 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 2001-05-07. Active ingredient: alemtuzumab. Sponsor: Genzyme. Application BLA103948.FDA Drugs@FDA, application BLA103948 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103948)
• Lumigan (bimatoprost)2001 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2001-03-16. Active ingredient: bimatoprost. Sponsor: Abbvie. Application NDA021275.FDA Drugs@FDA, application NDA021275 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021275)
• Pegintron (peginterferon alfa-2b)2001 · FDA new drug approval · Schering AG headquarters, BerlinNew drug approved by the FDA on 2001-01-19. Active ingredient: peginterferon alfa-2b. Sponsor: Schering. Application BLA103949.FDA Drugs@FDA, application BLA103949 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103949)
• Tracleer (bosentan)2001 · FDA new drug approval · Actelion (United States) headquarters, San FranciscoNew drug approved by the FDA on 2001-11-20. Active ingredient: bosentan. Sponsor: Actelion. Application NDA021290.FDA Drugs@FDA, application NDA021290 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021290)
• Viread (tenofovir disoproxil fumarate)2001 · FDA new drug approval · Gilead Sciences headquarters, Foster CityNew drug approved by the FDA on 2001-10-26. Active ingredient: tenofovir disoproxil fumarate. Sponsor: Gilead Sciences Inc. Application NDA021356.FDA Drugs@FDA, application NDA021356 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021356)
• Zometa (zoledronic acid)2001 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2001-08-20. Active ingredient: zoledronic acid. Sponsor: Novartis. Application NDA021223.FDA Drugs@FDA, application NDA021223 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021223)
• Abilify (aripiprazole)2002 · FDA new drug approval · Otsuka Pharmaceutical headquarters, ChiyodaNew drug approved by the FDA on 2002-11-15. Active ingredient: aripiprazole. Sponsor: Otsuka. Application NDA021436.FDA Drugs@FDA, application NDA021436 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021436)
• Alinia (nitazoxanide)2002 · FDA new drug approval · Romark (United States) headquarters, New drug approved by the FDA on 2002-11-22. Active ingredient: nitazoxanide. Sponsor: Romark. Application NDA021498.FDA Drugs@FDA, application NDA021498 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021498)
• Elitek (rasburicase)2002 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 2002-07-12. Active ingredient: rasburicase. Sponsor: Sanofi Synthelabo. Application BLA103946.FDA Drugs@FDA, application BLA103946 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103946)
• Eloxatin (oxaliplatin)2002 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 2002-08-09. Active ingredient: oxaliplatin. Sponsor: Sanofi Aventis Us. Application NDA021492.FDA Drugs@FDA, application NDA021492 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021492)
• Faslodex (fulvestrant)2002 · FDA new drug approval · AstraZeneca headquarters, CambridgeNew drug approved by the FDA on 2002-04-25. Active ingredient: fulvestrant. Sponsor: Astrazeneca. Application NDA021344.FDA Drugs@FDA, application NDA021344 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021344)
• Hepsera (adefovir dipivoxil)2002 · FDA new drug approval · Gilead Sciences headquarters, Foster CityNew drug approved by the FDA on 2002-09-20. Active ingredient: adefovir dipivoxil. Sponsor: Gilead. Application NDA021449.FDA Drugs@FDA, application NDA021449 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021449)
• Humira (adalimumab)2002 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2002-12-31. Active ingredient: adalimumab. Sponsor: Abbvie Inc. Application BLA125057.FDA Drugs@FDA, application BLA125057 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125057)
• Inspra (eplerenone)2002 · FDA new drug approval · Upjohn headquarters, MichiganNew drug approved by the FDA on 2002-09-27. Active ingredient: eplerenone. Sponsor: Upjohn. Application NDA021437.FDA Drugs@FDA, application NDA021437 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021437)
• Neulasta (pegfilgrastim)2002 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2002-01-31. Active ingredient: pegfilgrastim. Sponsor: Amgen. Application BLA125031.FDA Drugs@FDA, application BLA125031 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125031)
• Orfadin (nitisinone)2002 · FDA new drug approval · Swedish Orphan Biovitrum headquarters, StockholmNew drug approved by the FDA on 2002-01-18. Active ingredient: nitisinone. Sponsor: Swedish Orphan. Application NDA021232.FDA Drugs@FDA, application NDA021232 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021232)
• Rebif (interferon beta-1a)2002 · FDA new drug approval · Serono headquarters, GenevaNew drug approved by the FDA on 2002-03-07. Active ingredient: interferon beta-1a. Sponsor: Serono Inc. Application BLA103780.FDA Drugs@FDA, application BLA103780 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103780)
• Relpax (eletriptan hydrobromide)2002 · FDA new drug approval · Upjohn headquarters, MichiganNew drug approved by the FDA on 2002-12-26. Active ingredient: eletriptan hydrobromide. Sponsor: Upjohn. Application NDA021016.FDA Drugs@FDA, application NDA021016 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021016)
• Remodulin (treprostinil)2002 · FDA new drug approval · United Therapeutics headquarters, Silver SpringNew drug approved by the FDA on 2002-05-21. Active ingredient: treprostinil. Sponsor: United Therap. Application NDA021272.FDA Drugs@FDA, application NDA021272 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021272)
• Strattera (atomoxetine hydrochloride)2002 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2002-11-26. Active ingredient: atomoxetine hydrochloride. Sponsor: Lilly. Application NDA021411.FDA Drugs@FDA, application NDA021411 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021411)
• Zelnorm (tegaserod maleate)2002 · FDA new drug approval · Alfasigma headquarters, BolognaNew drug approved by the FDA on 2002-07-24. Active ingredient: tegaserod maleate. Sponsor: Alfasigma. Application NDA021200.FDA Drugs@FDA, application NDA021200 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021200)
• Zetia (ezetimibe)2002 · FDA new drug approval · Organon & Co. headquarters, OssNew drug approved by the FDA on 2002-10-25. Active ingredient: ezetimibe. Sponsor: Organon. Application NDA021445.FDA Drugs@FDA, application NDA021445 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021445)
• Aldurazyme (laronidase)2003 · FDA new drug approval · BioMarin Pharmaceutical headquarters, NovatoNew drug approved by the FDA on 2003-04-30. Active ingredient: laronidase. Sponsor: Biomarin. Application BLA125058.FDA Drugs@FDA, application BLA125058 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125058)
• Boniva (ibandronate sodium)2003 · FDA new drug approval · Hoffmann-La Roche headquarters, BaselNew drug approved by the FDA on 2003-05-16. Active ingredient: ibandronate sodium. Sponsor: Hoffmann La Roche. Application NDA021455.FDA Drugs@FDA, application NDA021455 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021455)
• Cialis (tadalafil)2003 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2003-11-21. Active ingredient: tadalafil. Sponsor: Lilly. Application NDA021368.FDA Drugs@FDA, application NDA021368 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021368)
• Crestor (rosuvastatin calcium)2003 · FDA new drug approval · AstraZeneca headquarters, CambridgeNew drug approved by the FDA on 2003-08-12. Active ingredient: rosuvastatin calcium. Sponsor: Astrazeneca. Application NDA021366.FDA Drugs@FDA, application NDA021366 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021366)
• Elestat (epinastine hydrochloride)2003 · FDA new drug approval · Allergan plc headquarters, IrelandNew drug approved by the FDA on 2003-10-16. Active ingredient: epinastine hydrochloride. Sponsor: Allergan. Application NDA021565.FDA Drugs@FDA, application NDA021565 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021565)
• Emend (aprepitant)2003 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2003-03-26. Active ingredient: aprepitant. Sponsor: Msd. Application NDA021549.FDA Drugs@FDA, application NDA021549 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021549)
• Emtriva (emtricitabine)2003 · FDA new drug approval · Gilead Sciences headquarters, Foster CityNew drug approved by the FDA on 2003-07-02. Active ingredient: emtricitabine. Sponsor: Gilead. Application NDA021500.FDA Drugs@FDA, application NDA021500 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021500)
• Fabrazyme (agalsidase beta)2003 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 2003-04-24. Active ingredient: agalsidase beta. Sponsor: Genzyme. Application BLA103979.FDA Drugs@FDA, application BLA103979 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103979)
• Factive (gemifloxacin mesylate)2003 · FDA new drug approval · LG Chem headquarters, SeoulNew drug approved by the FDA on 2003-04-04. Active ingredient: gemifloxacin mesylate. Sponsor: Lg Chem Ltd. Application NDA021158.FDA Drugs@FDA, application NDA021158 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021158)
• Iressa (gefitinib)2003 · FDA new drug approval · AstraZeneca headquarters, CambridgeNew drug approved by the FDA on 2003-05-05. Active ingredient: gefitinib. Sponsor: Astrazeneca. Application NDA021399.FDA Drugs@FDA, application NDA021399 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021399)
• Namenda (memantine hydrochloride)2003 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2003-10-16. Active ingredient: memantine hydrochloride. Sponsor: Abbvie. Application NDA021487.FDA Drugs@FDA, application NDA021487 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021487)
• Reyataz (atazanavir sulfate)2003 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2003-06-20. Active ingredient: atazanavir sulfate. Sponsor: Bristol Myers Squibb. Application NDA021567.FDA Drugs@FDA, application NDA021567 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021567)
• Somavert (pegvisomant)2003 · FDA new drug approval · Pharmacia headquarters, UppsalaNew drug approved by the FDA on 2003-03-25. Active ingredient: pegvisomant. Sponsor: Pharmacia. Application BLA021106.FDA Drugs@FDA, application BLA021106 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021106)
• Xolair (omalizumab)2003 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2003-06-20. Active ingredient: omalizumab. Sponsor: Genentech. Application BLA103976.FDA Drugs@FDA, application BLA103976 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103976)
• Zavesca (miglustat)2003 · FDA new drug approval · Actelion (United States) headquarters, San FranciscoNew drug approved by the FDA on 2003-07-31. Active ingredient: miglustat. Sponsor: Actelion. Application NDA021348.FDA Drugs@FDA, application NDA021348 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021348)
• Alimta (pemetrexed disodium)2004 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2004-02-04. Active ingredient: pemetrexed disodium. Sponsor: Lilly. Application NDA021462.FDA Drugs@FDA, application NDA021462 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021462)
• Apidra Solostar (insulin glulisine recombinant)2004 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 2004-04-16. Active ingredient: insulin glulisine recombinant. Sponsor: Sanofi Aventis Us. Application BLA021629.FDA Drugs@FDA, application BLA021629 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021629)
• Apokyn (apomorphine hydrochloride)2004 · FDA new drug approval · McDonnell Douglas headquarters, St. LouisNew drug approved by the FDA on 2004-04-20. Active ingredient: apomorphine hydrochloride. Sponsor: Mdd Us. Application NDA021264.FDA Drugs@FDA, application NDA021264 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021264)
• Avastin (bevacizumab)2004 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2004-02-26. Active ingredient: bevacizumab. Sponsor: Genentech. Application BLA125085.FDA Drugs@FDA, application BLA125085 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125085)
• Clolar (clofarabine)2004 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 2004-12-28. Active ingredient: clofarabine. Sponsor: Genzyme. Application NDA021673.FDA Drugs@FDA, application NDA021673 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021673)
• Cymbalta (duloxetine hydrochloride)2004 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2004-08-03. Active ingredient: duloxetine hydrochloride. Sponsor: Lilly. Application NDA021427.FDA Drugs@FDA, application NDA021427 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021427)
• Enablex (darifenacin hydrobromide)2004 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2004-12-22. Active ingredient: darifenacin hydrobromide. Sponsor: Abbvie. Application NDA021513.FDA Drugs@FDA, application NDA021513 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021513)
• Ketek (telithromycin)2004 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 2004-04-01. Active ingredient: telithromycin. Sponsor: Sanofi Aventis Us. Application NDA021144.FDA Drugs@FDA, application NDA021144 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021144)
• Lyrica (pregabalin)2004 · FDA new drug approval · Upjohn headquarters, MichiganNew drug approved by the FDA on 2004-12-30. Active ingredient: pregabalin. Sponsor: Upjohn. Application NDA021446.FDA Drugs@FDA, application NDA021446 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021446)
• Macugen (pegaptanib sodium)2004 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 2004-09-17. Active ingredient: pegaptanib sodium. Sponsor: Bausch And Lomb Inc. Application NDA021756.FDA Drugs@FDA, application NDA021756 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021756)
• Sanctura (trospium chloride)2004 · FDA new drug approval · Allergan plc headquarters, IrelandNew drug approved by the FDA on 2004-05-28. Active ingredient: trospium chloride. Sponsor: Allergan. Application NDA021595.FDA Drugs@FDA, application NDA021595 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021595)
• Sensipar (cinacalcet hydrochloride)2004 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2004-03-08. Active ingredient: cinacalcet hydrochloride. Sponsor: Amgen. Application NDA021688.FDA Drugs@FDA, application NDA021688 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021688)
• Spiriva (tiotropium bromide)2004 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 2004-01-30. Active ingredient: tiotropium bromide. Sponsor: Boehringer Ingelheim. Application NDA021395.FDA Drugs@FDA, application NDA021395 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021395)
• Tysabri (natalizumab)2004 · FDA new drug approval · Biogen headquarters, CambridgeNew drug approved by the FDA on 2004-11-23. Active ingredient: natalizumab. Sponsor: Biogen Idec. Application BLA125104.FDA Drugs@FDA, application BLA125104 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125104)
• Ventavis (iloprost)2004 · FDA new drug approval · Actelion (United States) headquarters, San FranciscoNew drug approved by the FDA on 2004-12-29. Active ingredient: iloprost. Sponsor: Actelion. Application NDA021779.FDA Drugs@FDA, application NDA021779 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021779)
• Vesicare (solifenacin succinate)2004 · FDA new drug approval · Astellas Pharma headquarters, ChūōNew drug approved by the FDA on 2004-11-19. Active ingredient: solifenacin succinate. Sponsor: Astellas. Application NDA021518.FDA Drugs@FDA, application NDA021518 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021518)
• Vidaza (azacitidine)2004 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2004-05-19. Active ingredient: azacitidine. Sponsor: Bristol-Myers. Application NDA050794.FDA Drugs@FDA, application NDA050794 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050794)
• Vitrase (hyaluronidase)2004 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 2004-05-05. Active ingredient: hyaluronidase. Sponsor: Bausch And Lomb. Application BLA021640.FDA Drugs@FDA, application BLA021640 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021640)
• Aptivus (tipranavir)2005 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 2005-06-22. Active ingredient: tipranavir. Sponsor: Boehringer Ingelheim. Application NDA021814.FDA Drugs@FDA, application NDA021814 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021814)
• Arranon (nelarabine)2005 · FDA new drug approval · Sandoz headquarters, BaselNew drug approved by the FDA on 2005-10-28. Active ingredient: nelarabine. Sponsor: Sandoz. Application NDA021877.FDA Drugs@FDA, application NDA021877 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021877)
• Baraclude (entecavir)2005 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2005-03-29. Active ingredient: entecavir. Sponsor: Bristol Myers Squibb. Application NDA021797.FDA Drugs@FDA, application NDA021797 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021797)
• Byetta (exenatide synthetic)2005 · FDA new drug approval · AstraZeneca AB headquarters, SödertäljeNew drug approved by the FDA on 2005-04-28. Active ingredient: exenatide synthetic. Sponsor: Astrazeneca Ab. Application NDA021773.FDA Drugs@FDA, application NDA021773 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021773)
• Exjade (deferasirox)2005 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2005-11-02. Active ingredient: deferasirox. Sponsor: Novartis. Application NDA021882.FDA Drugs@FDA, application NDA021882 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021882)
• Hydase (hyaluronidase)2005 · FDA new drug approval · Akorn headquarters, Lake ForestNew drug approved by the FDA on 2005-10-25. Active ingredient: hyaluronidase. Sponsor: Akorn Inc. Application BLA021716.FDA Drugs@FDA, application BLA021716 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021716)
• Levemir Flextouch (insulin detemir recombinant)2005 · FDA new drug approval · Novo headquarters, BagsværdNew drug approved by the FDA on 2005-06-16. Active ingredient: insulin detemir recombinant. Sponsor: Novo Nordisk Inc. Application BLA021536.FDA Drugs@FDA, application BLA021536 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021536)
• Mycamine (micafungin sodium)2005 · FDA new drug approval · Astellas Pharma headquarters, ChūōNew drug approved by the FDA on 2005-03-16. Active ingredient: micafungin sodium. Sponsor: Astellas. Application NDA021506.FDA Drugs@FDA, application NDA021506 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021506)
• Naglazyme (galsulfase)2005 · FDA new drug approval · BioMarin Pharmaceutical headquarters, NovatoNew drug approved by the FDA on 2005-05-31. Active ingredient: galsulfase. Sponsor: Biomarin. Application BLA125117.FDA Drugs@FDA, application BLA125117 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125117)
• Orencia (abatacept)2005 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2005-12-23. Active ingredient: abatacept. Sponsor: Bristol Myers Squibb. Application BLA125118.FDA Drugs@FDA, application BLA125118 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125118)
• Revlimid (lenalidomide)2005 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2005-12-27. Active ingredient: lenalidomide. Sponsor: Bristol Myers Squibb. Application NDA021880.FDA Drugs@FDA, application NDA021880 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021880)
• Symlin (pramlintide acetate)2005 · FDA new drug approval · AstraZeneca AB headquarters, SödertäljeNew drug approved by the FDA on 2005-03-16. Active ingredient: pramlintide acetate. Sponsor: Astrazeneca Ab. Application NDA021332.FDA Drugs@FDA, application NDA021332 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021332)
• Vaprisol In 5% Dextrose In Plastic Container (conivaptan hydrochloride)2005 · FDA new drug approval · Apotex headquarters, TorontoNew drug approved by the FDA on 2005-12-29. Active ingredient: conivaptan hydrochloride. Sponsor: Apotex. Application NDA021697.FDA Drugs@FDA, application NDA021697 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021697)
• Amitiza (lubiprostone)2006 · FDA new drug approval · Sucampo Pharmaceuticals headquarters, RockvilleNew drug approved by the FDA on 2006-01-31. Active ingredient: lubiprostone. Sponsor: Sucampo Pharma Llc. Application NDA021908.FDA Drugs@FDA, application NDA021908 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021908)
• Dacogen (decitabine)2006 · FDA new drug approval · Otsuka Pharmaceutical headquarters, ChiyodaNew drug approved by the FDA on 2006-05-02. Active ingredient: decitabine. Sponsor: Otsuka. Application NDA021790.FDA Drugs@FDA, application NDA021790 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021790)
• Elaprase (idursulfase)2006 · FDA new drug approval · Shire plc headquarters, BasingstokeNew drug approved by the FDA on 2006-07-24. Active ingredient: idursulfase. Sponsor: Shire. Application BLA125151.FDA Drugs@FDA, application BLA125151 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125151)
• Eraxis (anidulafungin)2006 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2006-02-17. Active ingredient: anidulafungin. Sponsor: Vicuron Holdings. Application NDA021632.FDA Drugs@FDA, application NDA021632 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021632)
• Januvia (sitagliptin phosphate)2006 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2006-10-16. Active ingredient: sitagliptin phosphate. Sponsor: Msd. Application NDA021995.FDA Drugs@FDA, application NDA021995 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021995)
• Lucentis (ranibizumab)2006 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2006-06-30. Active ingredient: ranibizumab. Sponsor: Genentech. Application BLA125156.FDA Drugs@FDA, application BLA125156 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125156)
• Myozyme (alglucosidase alfa)2006 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 2006-04-28. Active ingredient: alglucosidase alfa. Sponsor: Genzyme. Application BLA125141.FDA Drugs@FDA, application BLA125141 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125141)
• Noxafil (posaconazole)2006 · FDA new drug approval · Schering AG headquarters, BerlinNew drug approved by the FDA on 2006-09-15. Active ingredient: posaconazole. Sponsor: Schering. Application NDA022003.FDA Drugs@FDA, application NDA022003 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022003)
• Sprycel (dasatinib)2006 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2006-06-28. Active ingredient: dasatinib. Sponsor: Bristol Myers Squibb. Application NDA021986.FDA Drugs@FDA, application NDA021986 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021986)
• Tyzeka (telbivudine)2006 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2006-10-25. Active ingredient: telbivudine. Sponsor: Novartis. Application NDA022011.FDA Drugs@FDA, application NDA022011 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022011)
• Vectibix (panitumumab)2006 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2006-09-27. Active ingredient: panitumumab. Sponsor: Amgen. Application BLA125147.FDA Drugs@FDA, application BLA125147 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125147)
• Altabax (retapamulin)2007 · FDA new drug approval · Almirall headquarters, BarcelonaNew drug approved by the FDA on 2007-04-12. Active ingredient: retapamulin. Sponsor: Almirall. Application NDA022055.FDA Drugs@FDA, application NDA022055 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022055)
• Bystolic (nebivolol hydrochloride)2007 · FDA new drug approval · Allergan plc headquarters, IrelandNew drug approved by the FDA on 2007-12-17. Active ingredient: nebivolol hydrochloride. Sponsor: Allergan. Application NDA021742.FDA Drugs@FDA, application NDA021742 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021742)
• Doribax (doripenem)2007 · FDA new drug approval · Shionogi headquarters, Chūō-kuNew drug approved by the FDA on 2007-10-12. Active ingredient: doripenem. Sponsor: Shionogi. Application NDA022106.FDA Drugs@FDA, application NDA022106 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022106)
• Ixempra Kit (ixabepilone)2007 · FDA new drug approval · R-Pharm headquarters, MoscowNew drug approved by the FDA on 2007-10-16. Active ingredient: ixabepilone. Sponsor: R-Pharm Us Llc. Application NDA022065.FDA Drugs@FDA, application NDA022065 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022065)
• Kuvan (sapropterin dihydrochloride)2007 · FDA new drug approval · BioMarin Pharmaceutical headquarters, NovatoNew drug approved by the FDA on 2007-12-13. Active ingredient: sapropterin dihydrochloride. Sponsor: Biomarin Pharm. Application NDA022181.FDA Drugs@FDA, application NDA022181 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022181)
• Letairis (ambrisentan)2007 · FDA new drug approval · Gilead Sciences headquarters, Foster CityNew drug approved by the FDA on 2007-06-15. Active ingredient: ambrisentan. Sponsor: Gilead. Application NDA022081.FDA Drugs@FDA, application NDA022081 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022081)
• Neupro (rotigotine)2007 · FDA new drug approval · UCB headquarters, Brussels metropolitan areaNew drug approved by the FDA on 2007-05-09. Active ingredient: rotigotine. Sponsor: Ucb Inc. Application NDA021829.FDA Drugs@FDA, application NDA021829 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021829)
• Soliris (eculizumab)2007 · FDA new drug approval · Alexion Pharmaceuticals headquarters, CheshireNew drug approved by the FDA on 2007-03-16. Active ingredient: eculizumab. Sponsor: Alexion Pharm. Application BLA125166.FDA Drugs@FDA, application BLA125166 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125166)
• Tasigna (nilotinib hydrochloride)2007 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2007-10-29. Active ingredient: nilotinib hydrochloride. Sponsor: Novartis. Application NDA022068.FDA Drugs@FDA, application NDA022068 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022068)
• Tykerb (lapatinib ditosylate)2007 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2007-03-13. Active ingredient: lapatinib ditosylate. Sponsor: Novartis. Application NDA022059.FDA Drugs@FDA, application NDA022059 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022059)
• Adreview (iobenguane sulfate i-123)2008 · FDA new drug approval · GE HealthCare headquarters, Little ChalfontNew drug approved by the FDA on 2008-09-19. Active ingredient: iobenguane sulfate i-123. Sponsor: Ge Healthcare. Application NDA022290.FDA Drugs@FDA, application NDA022290 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022290)
• Banzel (rufinamide)2008 · FDA new drug approval · Eisai headquarters, TokyoNew drug approved by the FDA on 2008-11-14. Active ingredient: rufinamide. Sponsor: Eisai Inc. Application NDA021911.FDA Drugs@FDA, application NDA021911 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021911)
• Cimzia (certolizumab pegol)2008 · FDA new drug approval · UCB headquarters, Brussels metropolitan areaNew drug approved by the FDA on 2008-04-22. Active ingredient: certolizumab pegol. Sponsor: Ucb Inc. Application BLA125160.FDA Drugs@FDA, application BLA125160 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125160)
• Cleviprex (clevidipine)2008 · FDA new drug approval · Chiesi Farmaceutici S.p.A. headquarters, ParmaNew drug approved by the FDA on 2008-08-01. Active ingredient: clevidipine. Sponsor: Chiesi. Application NDA022156.FDA Drugs@FDA, application NDA022156 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022156)
• Durezol (difluprednate)2008 · FDA new drug approval · Sandoz headquarters, BaselNew drug approved by the FDA on 2008-06-23. Active ingredient: difluprednate. Sponsor: Sandoz. Application NDA022212.FDA Drugs@FDA, application NDA022212 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022212)
• Emend (fosaprepitant dimeglumine)2008 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2008-01-25. Active ingredient: fosaprepitant dimeglumine. Sponsor: Merck And Co Inc. Application NDA022023.FDA Drugs@FDA, application NDA022023 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022023)
• Lexiscan (regadenoson)2008 · FDA new drug approval · Astellas Pharma headquarters, ChūōNew drug approved by the FDA on 2008-04-10. Active ingredient: regadenoson. Sponsor: Astellas. Application NDA022161.FDA Drugs@FDA, application NDA022161 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022161)
• Lusedra (fospropofol disodium)2008 · FDA new drug approval · Eisai headquarters, TokyoNew drug approved by the FDA on 2008-12-08. Active ingredient: fospropofol disodium. Sponsor: Eisai Inc. Application NDA022244.FDA Drugs@FDA, application NDA022244 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022244)
• Mozobil (plerixafor)2008 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 2008-12-15. Active ingredient: plerixafor. Sponsor: Genzyme. Application NDA022311.FDA Drugs@FDA, application NDA022311 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022311)
• Nplate (romiplostim)2008 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2008-08-22. Active ingredient: romiplostim. Sponsor: Amgen. Application BLA125268.FDA Drugs@FDA, application BLA125268 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125268)
• Nucynta (tapentadol hydrochloride)2008 · FDA new drug approval · Collegium Pharmaceutical (United States) headquarters, CumberlandNew drug approved by the FDA on 2008-11-20. Active ingredient: tapentadol hydrochloride. Sponsor: Collegium Pharm Inc. Application NDA022304.FDA Drugs@FDA, application NDA022304 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022304)
• Promacta (eltrombopag olamine)2008 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2008-11-20. Active ingredient: eltrombopag olamine. Sponsor: Novartis. Application NDA022291.FDA Drugs@FDA, application NDA022291 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022291)
• Rapaflo (silodosin)2008 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2008-10-08. Active ingredient: silodosin. Sponsor: Abbvie. Application NDA022206.FDA Drugs@FDA, application NDA022206 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022206)
• Toviaz (fesoterodine fumarate)2008 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2008-10-31. Active ingredient: fesoterodine fumarate. Sponsor: Pfizer. Application NDA022030.FDA Drugs@FDA, application NDA022030 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022030)
• Vimpat (lacosamide)2008 · FDA new drug approval · UCB headquarters, Brussels metropolitan areaNew drug approved by the FDA on 2008-10-28. Active ingredient: lacosamide. Sponsor: Ucb Inc. Application NDA022253.FDA Drugs@FDA, application NDA022253 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022253)
• Xenazine (tetrabenazine)2008 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 2008-08-15. Active ingredient: tetrabenazine. Sponsor: Bausch. Application NDA021894.FDA Drugs@FDA, application NDA021894 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021894)
• Afinitor (everolimus)2009 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2009-03-30. Active ingredient: everolimus. Sponsor: Novartis. Application NDA022334.FDA Drugs@FDA, application NDA022334 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022334)
• Bepreve (bepotastine besilate)2009 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 2009-09-08. Active ingredient: bepotastine besilate. Sponsor: Bausch And Lomb Inc. Application NDA022288.FDA Drugs@FDA, application NDA022288 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022288)
• Besivance (besifloxacin hydrochloride)2009 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 2009-05-28. Active ingredient: besifloxacin hydrochloride. Sponsor: Bausch And Lomb. Application NDA022308.FDA Drugs@FDA, application NDA022308 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022308)
• Coartem (artemether, lumefantrine)2009 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2009-04-07. Active ingredient: artemether, lumefantrine. Sponsor: Novartis. Application NDA022268.FDA Drugs@FDA, application NDA022268 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022268)
• Istodax (romidepsin)2009 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2009-11-05. Active ingredient: romidepsin. Sponsor: Bristol-Myers. Application NDA022393.FDA Drugs@FDA, application NDA022393 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022393)
• Kalbitor (ecallantide)2009 · FDA new drug approval · Dyax (United States) headquarters, BurlingtonNew drug approved by the FDA on 2009-12-01. Active ingredient: ecallantide. Sponsor: Dyax Corp.. Application BLA125277.FDA Drugs@FDA, application BLA125277 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125277)
• Kesimpta (ofatumumab)2009 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2009-10-26. Active ingredient: ofatumumab. Sponsor: Novartis. Application BLA125326.FDA Drugs@FDA, application BLA125326 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125326)
• Multaq (dronedarone hydrochloride)2009 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 2009-07-01. Active ingredient: dronedarone hydrochloride. Sponsor: Sanofi Aventis Us. Application NDA022425.FDA Drugs@FDA, application NDA022425 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022425)
• Onglyza (saxagliptin hydrochloride)2009 · FDA new drug approval · AstraZeneca AB headquarters, SödertäljeNew drug approved by the FDA on 2009-07-31. Active ingredient: saxagliptin hydrochloride. Sponsor: Astrazeneca Ab. Application NDA022350.FDA Drugs@FDA, application NDA022350 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022350)
• Samsca (tolvaptan)2009 · FDA new drug approval · Otsuka Pharmaceutical headquarters, ChiyodaNew drug approved by the FDA on 2009-05-19. Active ingredient: tolvaptan. Sponsor: Otsuka. Application NDA022275.FDA Drugs@FDA, application NDA022275 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022275)
• Saphris (asenapine maleate)2009 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2009-08-13. Active ingredient: asenapine maleate. Sponsor: Abbvie. Application NDA022117.FDA Drugs@FDA, application NDA022117 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022117)
• Savella (milnacipran hydrochloride)2009 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2009-01-14. Active ingredient: milnacipran hydrochloride. Sponsor: Abbvie. Application NDA022256.FDA Drugs@FDA, application NDA022256 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022256)
• Simponi (golimumab)2009 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 2009-04-24. Active ingredient: golimumab. Sponsor: Centocor Ortho Biotech Inc. Application BLA125289.FDA Drugs@FDA, application BLA125289 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125289)
• Stelara (ustekinumab)2009 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 2009-09-25. Active ingredient: ustekinumab. Sponsor: Centocor Ortho Biotech Inc. Application BLA125261.FDA Drugs@FDA, application BLA125261 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125261)
• Ulesfia (benzyl alcohol)2009 · FDA new drug approval · Shionogi headquarters, Chūō-kuNew drug approved by the FDA on 2009-04-09. Active ingredient: benzyl alcohol. Sponsor: Shionogi. Application NDA022129.FDA Drugs@FDA, application NDA022129 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022129)
• Vibativ (telavancin hydrochloride)2009 · FDA new drug approval · Apotex headquarters, TorontoNew drug approved by the FDA on 2009-09-11. Active ingredient: telavancin hydrochloride. Sponsor: Apotex. Application NDA022110.FDA Drugs@FDA, application NDA022110 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022110)
• Votrient (pazopanib hydrochloride)2009 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2009-10-19. Active ingredient: pazopanib hydrochloride. Sponsor: Novartis. Application NDA022465.FDA Drugs@FDA, application NDA022465 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022465)
• Actemra (tocilizumab)2010 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2010-01-08. Active ingredient: tocilizumab. Sponsor: Genentech. Application BLA125276.FDA Drugs@FDA, application BLA125276 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125276)
• Gilenya (fingolimod hydrochloride)2010 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2010-09-21. Active ingredient: fingolimod hydrochloride. Sponsor: Novartis. Application NDA022527.FDA Drugs@FDA, application NDA022527 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022527)
• Halaven (eribulin mesylate)2010 · FDA new drug approval · Eisai headquarters, TokyoNew drug approved by the FDA on 2010-11-15. Active ingredient: eribulin mesylate. Sponsor: Eisai Inc. Application NDA201532.FDA Drugs@FDA, application NDA201532 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201532)
• Jevtana Kit (cabazitaxel)2010 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 2010-06-17. Active ingredient: cabazitaxel. Sponsor: Sanofi Aventis Us. Application NDA201023.FDA Drugs@FDA, application NDA201023 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201023)
• Lastacaft (alcaftadine)2010 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2010-07-28. Active ingredient: alcaftadine. Sponsor: Abbvie. Application NDA022134.FDA Drugs@FDA, application NDA022134 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022134)
• Lumizyme (alglucosidase alfa)2010 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 2010-05-24. Active ingredient: alglucosidase alfa. Sponsor: Genzyme. Application BLA125291.FDA Drugs@FDA, application BLA125291 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125291)
• Pradaxa (dabigatran etexilate mesylate)2010 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 2010-10-19. Active ingredient: dabigatran etexilate mesylate. Sponsor: Boehringer Ingelheim. Application NDA022512.FDA Drugs@FDA, application NDA022512 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022512)
• Prolia (denosumab)2010 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2010-06-01. Active ingredient: denosumab. Sponsor: Amgen. Application BLA125320.FDA Drugs@FDA, application BLA125320 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125320)
• Teflaro (ceftaroline fosamil)2010 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2010-10-29. Active ingredient: ceftaroline fosamil. Sponsor: Abbvie. Application NDA200327.FDA Drugs@FDA, application NDA200327 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=200327)
• Victoza (liraglutide)2010 · FDA new drug approval · Novo headquarters, BagsværdNew drug approved by the FDA on 2010-01-25. Active ingredient: liraglutide. Sponsor: Novo Nordisk Inc. Application NDA022341.FDA Drugs@FDA, application NDA022341 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022341)
• Adcetris (brentuximab vedotin)2011 · FDA new drug approval · Seagen headquarters, BothellNew drug approved by the FDA on 2011-08-19. Active ingredient: brentuximab vedotin. Sponsor: Seattle Genetics. Application BLA125388.FDA Drugs@FDA, application BLA125388 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125388)
• Arcapta Neohaler (indacaterol maleate)2011 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2011-07-01. Active ingredient: indacaterol maleate. Sponsor: Novartis. Application NDA022383.FDA Drugs@FDA, application NDA022383 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022383)
• Benlysta (belimumab)2011 · FDA new drug approval · Human Genome Sciences headquarters, RockvilleNew drug approved by the FDA on 2011-03-09. Active ingredient: belimumab. Sponsor: Human Genome Sciences Inc.. Application BLA125370.FDA Drugs@FDA, application BLA125370 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125370)
• Brilinta (ticagrelor)2011 · FDA new drug approval · AstraZeneca headquarters, CambridgeNew drug approved by the FDA on 2011-07-20. Active ingredient: ticagrelor. Sponsor: Astrazeneca. Application NDA022433.FDA Drugs@FDA, application NDA022433 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022433)
• Caprelsa (vandetanib)2011 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 2011-04-06. Active ingredient: vandetanib. Sponsor: Genzyme Corp. Application NDA022405.FDA Drugs@FDA, application NDA022405 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022405)
• Daliresp (roflumilast)2011 · FDA new drug approval · AstraZeneca headquarters, CambridgeNew drug approved by the FDA on 2011-02-28. Active ingredient: roflumilast. Sponsor: Astrazeneca. Application NDA022522.FDA Drugs@FDA, application NDA022522 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022522)
• Eylea (aflibercept)2011 · FDA new drug approval · Regeneron Pharmaceuticals headquarters, EastviewNew drug approved by the FDA on 2011-11-18. Active ingredient: aflibercept. Sponsor: Regeneron Pharmaceuticals. Application BLA125387.FDA Drugs@FDA, application BLA125387 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125387)
• Ferriprox (deferiprone)2011 · FDA new drug approval · Chiesi Farmaceutici S.p.A. headquarters, ParmaNew drug approved by the FDA on 2011-10-14. Active ingredient: deferiprone. Sponsor: Chiesi. Application NDA021825.FDA Drugs@FDA, application NDA021825 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021825)
• Jakafi (ruxolitinib phosphate)2011 · FDA new drug approval · Incyte headquarters, WilmingtonNew drug approved by the FDA on 2011-11-16. Active ingredient: ruxolitinib phosphate. Sponsor: Incyte Corp. Application NDA202192.FDA Drugs@FDA, application NDA202192 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202192)
• Nulojix (belatacept)2011 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2011-06-15. Active ingredient: belatacept. Sponsor: Bristol Myers Squibb. Application BLA125288.FDA Drugs@FDA, application BLA125288 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125288)
• Potiga (ezogabine)2011 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 2011-06-10. Active ingredient: ezogabine. Sponsor: Glaxosmithkline. Application NDA022345.FDA Drugs@FDA, application NDA022345 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022345)
• Tradjenta (linagliptin)2011 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 2011-05-02. Active ingredient: linagliptin. Sponsor: Boehringer Ingelheim. Application NDA201280.FDA Drugs@FDA, application NDA201280 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201280)
• Viibryd (vilazodone hydrochloride)2011 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2011-01-21. Active ingredient: vilazodone hydrochloride. Sponsor: Abbvie. Application NDA022567.FDA Drugs@FDA, application NDA022567 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022567)
• Yervoy (ipilimumab)2011 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2011-03-25. Active ingredient: ipilimumab. Sponsor: Bristol Myers Squibb. Application BLA125377.FDA Drugs@FDA, application BLA125377 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125377)
• Zelboraf (vemurafenib)2011 · FDA new drug approval · Hoffmann-La Roche headquarters, BaselNew drug approved by the FDA on 2011-08-17. Active ingredient: vemurafenib. Sponsor: Hoffmann La Roche. Application NDA202429.FDA Drugs@FDA, application NDA202429 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202429)
• Zytiga (abiraterone acetate)2011 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 2011-04-28. Active ingredient: abiraterone acetate. Sponsor: Janssen Biotech. Application NDA202379.FDA Drugs@FDA, application NDA202379 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202379)
• Aubagio (teriflunomide)2012 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 2012-09-12. Active ingredient: teriflunomide. Sponsor: Sanofi Aventis Us. Application NDA202992.FDA Drugs@FDA, application NDA202992 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202992)
• Cometriq (cabozantinib s-malate)2012 · FDA new drug approval · Exelixis headquarters, South San FranciscoNew drug approved by the FDA on 2012-11-29. Active ingredient: cabozantinib s-malate. Sponsor: Exelixis. Application NDA203756.FDA Drugs@FDA, application NDA203756 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203756)
• Elelyso (taliglucerase alfa)2012 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2012-05-01. Active ingredient: taliglucerase alfa. Sponsor: Pfizer. Application BLA022458.FDA Drugs@FDA, application BLA022458 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022458)
• Eliquis (apixaban)2012 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2012-12-28. Active ingredient: apixaban. Sponsor: Bristol Myers Squibb. Application NDA202155.FDA Drugs@FDA, application NDA202155 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202155)
• Erivedge (vismodegib)2012 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2012-01-30. Active ingredient: vismodegib. Sponsor: Genentech. Application NDA203388.FDA Drugs@FDA, application NDA203388 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203388)
• Granix (tbo-filgrastim)2012 · FDA new drug approval · Teva Pharmaceutical Industries Ltd. headquarters, Ramat HaHayalNew drug approved by the FDA on 2012-08-29. Active ingredient: tbo-filgrastim. Sponsor: Sicor Biotech. Application BLA125294.FDA Drugs@FDA, application BLA125294 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125294)
• Jetrea (ocriplasmin)2012 · FDA new drug approval · ThromboGenics headquarters, HeverleeNew drug approved by the FDA on 2012-10-17. Active ingredient: ocriplasmin. Sponsor: Thrombogenics, Inc. Application BLA125422.FDA Drugs@FDA, application BLA125422 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125422)
• Juxtapid (lomitapide mesylate)2012 · FDA new drug approval · Chiesi Farmaceutici S.p.A. headquarters, ParmaNew drug approved by the FDA on 2012-12-21. Active ingredient: lomitapide mesylate. Sponsor: Chiesi. Application NDA203858.FDA Drugs@FDA, application NDA203858 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203858)
• Linzess (linaclotide)2012 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2012-08-30. Active ingredient: linaclotide. Sponsor: Abbvie. Application NDA202811.FDA Drugs@FDA, application NDA202811 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202811)
• Perjeta (pertuzumab)2012 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2012-06-08. Active ingredient: pertuzumab. Sponsor: Genentech. Application BLA125409.FDA Drugs@FDA, application BLA125409 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125409)
• Raxibacumab (raxibacumab)2012 · FDA new drug approval · Human Genome Sciences headquarters, RockvilleNew drug approved by the FDA on 2012-12-14. Active ingredient: raxibacumab. Sponsor: Human Genome Sciences Inc.. Application BLA125349.FDA Drugs@FDA, application BLA125349 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125349)
• Stendra (avanafil)2012 · FDA new drug approval · Vivus headquarters, Mountain ViewNew drug approved by the FDA on 2012-04-27. Active ingredient: avanafil. Sponsor: Vivus Llc. Application NDA202276.FDA Drugs@FDA, application NDA202276 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202276)
• Xtandi (enzalutamide)2012 · FDA new drug approval · Astellas Pharma headquarters, ChūōNew drug approved by the FDA on 2012-08-31. Active ingredient: enzalutamide. Sponsor: Astellas. Application NDA203415.FDA Drugs@FDA, application NDA203415 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203415)
• Zaltrap (ziv-aflibercept)2012 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 2012-08-03. Active ingredient: ziv-aflibercept. Sponsor: Sanofi Aventis Us. Application BLA125418.FDA Drugs@FDA, application BLA125418 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125418)
• Dotarem (gadoterate meglumine)2013 · FDA new drug approval · Guerbet headquarters, VillepinteNew drug approved by the FDA on 2013-03-20. Active ingredient: gadoterate meglumine. Sponsor: Guerbet. Application NDA204781.FDA Drugs@FDA, application NDA204781 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204781)
• Gazyva (obinutuzumab)2013 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2013-11-01. Active ingredient: obinutuzumab. Sponsor: Genentech. Application BLA125486.FDA Drugs@FDA, application BLA125486 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125486)
• Gilotrif (afatinib dimaleate)2013 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 2013-07-12. Active ingredient: afatinib dimaleate. Sponsor: Boehringer Ingelheim. Application NDA201292.FDA Drugs@FDA, application NDA201292 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201292)
• Imbruvica (ibrutinib)2013 · FDA new drug approval · Pharmacyclics headquarters, SunnyvaleNew drug approved by the FDA on 2013-11-13. Active ingredient: ibrutinib. Sponsor: Pharmacyclics Llc. Application NDA205552.FDA Drugs@FDA, application NDA205552 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205552)
• Kadcyla (ado-trastuzumab emtansine)2013 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2013-02-22. Active ingredient: ado-trastuzumab emtansine. Sponsor: Genentech. Application BLA125427.FDA Drugs@FDA, application BLA125427 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125427)
• Luzu (luliconazole)2013 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 2013-11-14. Active ingredient: luliconazole. Sponsor: Bausch. Application NDA204153.FDA Drugs@FDA, application NDA204153 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204153)
• Mekinist (trametinib dimethyl sulfoxide)2013 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2013-05-29. Active ingredient: trametinib dimethyl sulfoxide. Sponsor: Novartis. Application NDA204114.FDA Drugs@FDA, application NDA204114 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204114)
• Opsumit (macitentan)2013 · FDA new drug approval · Actelion (United States) headquarters, San FranciscoNew drug approved by the FDA on 2013-10-18. Active ingredient: macitentan. Sponsor: Actelion. Application NDA204410.FDA Drugs@FDA, application NDA204410 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204410)
• Sovaldi (sofosbuvir)2013 · FDA new drug approval · Gilead Sciences headquarters, Foster CityNew drug approved by the FDA on 2013-12-06. Active ingredient: sofosbuvir. Sponsor: Gilead Sciences Inc. Application NDA204671.FDA Drugs@FDA, application NDA204671 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204671)
• Tafinlar (dabrafenib mesylate)2013 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2013-05-29. Active ingredient: dabrafenib mesylate. Sponsor: Novartis. Application NDA202806.FDA Drugs@FDA, application NDA202806 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202806)
• Tecfidera (dimethyl fumarate)2013 · FDA new drug approval · Biogen headquarters, CambridgeNew drug approved by the FDA on 2013-03-27. Active ingredient: dimethyl fumarate. Sponsor: Biogen. Application NDA204063.FDA Drugs@FDA, application NDA204063 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204063)
• Vizamyl (flutemetamol f-18)2013 · FDA new drug approval · GE HealthCare headquarters, Little ChalfontNew drug approved by the FDA on 2013-10-25. Active ingredient: flutemetamol f-18. Sponsor: Ge Healthcare. Application NDA203137.FDA Drugs@FDA, application NDA203137 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203137)
• Belsomra (suvorexant)2014 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2014-08-13. Active ingredient: suvorexant. Sponsor: Merck Sharp Dohme. Application NDA204569.FDA Drugs@FDA, application NDA204569 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204569)
• Blincyto (blinatumomab)2014 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2014-12-03. Active ingredient: blinatumomab. Sponsor: Amgen. Application BLA125557.FDA Drugs@FDA, application BLA125557 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125557)
• Cerdelga (eliglustat tartrate)2014 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 2014-08-19. Active ingredient: eliglustat tartrate. Sponsor: Genzyme Corp. Application NDA205494.FDA Drugs@FDA, application NDA205494 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205494)
• Cyramza (ramucirumab)2014 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2014-04-21. Active ingredient: ramucirumab. Sponsor: Eli Lilly And Co. Application BLA125477.FDA Drugs@FDA, application BLA125477 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125477)
• Dalvance (dalbavancin hydrochloride)2014 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2014-05-23. Active ingredient: dalbavancin hydrochloride. Sponsor: Abbvie. Application NDA021883.FDA Drugs@FDA, application NDA021883 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021883)
• Farxiga (dapagliflozin)2014 · FDA new drug approval · AstraZeneca AB headquarters, SödertäljeNew drug approved by the FDA on 2014-01-08. Active ingredient: dapagliflozin. Sponsor: Astrazeneca Ab. Application NDA202293.FDA Drugs@FDA, application NDA202293 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202293)
• Jardiance (empagliflozin)2014 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 2014-08-01. Active ingredient: empagliflozin. Sponsor: Boehringer Ingelheim. Application NDA204629.FDA Drugs@FDA, application NDA204629 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204629)
• Jublia (efinaconazole)2014 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 2014-06-06. Active ingredient: efinaconazole. Sponsor: Bausch. Application NDA203567.FDA Drugs@FDA, application NDA203567 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203567)
• Keytruda (pembrolizumab)2014 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2014-09-04. Active ingredient: pembrolizumab. Sponsor: Merck Sharp Dohme. Application BLA125514.FDA Drugs@FDA, application BLA125514 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514)
• Lynparza (olaparib)2014 · FDA new drug approval · AstraZeneca headquarters, CambridgeNew drug approved by the FDA on 2014-12-19. Active ingredient: olaparib. Sponsor: Astrazeneca. Application NDA206162.FDA Drugs@FDA, application NDA206162 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206162)
• Myalept (metreleptin)2014 · FDA new drug approval · Chiesi Farmaceutici S.p.A. headquarters, ParmaNew drug approved by the FDA on 2014-02-24. Active ingredient: metreleptin. Sponsor: Chiesi Farmaceutici Spa. Application BLA125390.FDA Drugs@FDA, application BLA125390 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125390)
• Neuraceq (florbetaben f-18)2014 · FDA new drug approval · Lantheus Medical Imaging (United States) headquarters, BillericaNew drug approved by the FDA on 2014-03-19. Active ingredient: florbetaben f-18. Sponsor: Lantheus. Application NDA204677.FDA Drugs@FDA, application NDA204677 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204677)
• Ofev (nintedanib esylate)2014 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 2014-10-15. Active ingredient: nintedanib esylate. Sponsor: Boehringer Ingelheim. Application NDA205832.FDA Drugs@FDA, application NDA205832 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205832)
• Opdivo (nivolumab)2014 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2014-12-22. Active ingredient: nivolumab. Sponsor: Bristol Myers Squibb. Application BLA125554.FDA Drugs@FDA, application BLA125554 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554)
• Orbactiv (oritavancin diphosphate)2014 · FDA new drug approval · Melinta Therapeutics headquarters, New HavenNew drug approved by the FDA on 2014-08-06. Active ingredient: oritavancin diphosphate. Sponsor: Melinta Therap. Application NDA206334.FDA Drugs@FDA, application NDA206334 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206334)
• Otezla (apremilast)2014 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2014-03-21. Active ingredient: apremilast. Sponsor: Amgen Inc. Application NDA205437.FDA Drugs@FDA, application NDA205437 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205437)
• Plegridy (peginterferon beta-1a)2014 · FDA new drug approval · Biogen headquarters, CambridgeNew drug approved by the FDA on 2014-08-15. Active ingredient: peginterferon beta-1a. Sponsor: Biogen Idec Inc. Application BLA125499.FDA Drugs@FDA, application BLA125499 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125499)
• Rapivab (peramivir)2014 · FDA new drug approval · BioCryst Pharmaceuticals headquarters, DurhamNew drug approved by the FDA on 2014-12-19. Active ingredient: peramivir. Sponsor: Biocryst. Application NDA206426.FDA Drugs@FDA, application NDA206426 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206426)
• Striverdi Respimat (olodaterol hydrochloride)2014 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 2014-07-31. Active ingredient: olodaterol hydrochloride. Sponsor: Boehringer Ingelheim. Application NDA203108.FDA Drugs@FDA, application NDA203108 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203108)
• Tanzeum (albiglutide)2014 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 2014-04-15. Active ingredient: albiglutide. Sponsor: Glaxosmithkline Llc. Application BLA125431.FDA Drugs@FDA, application BLA125431 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125431)
• Trulicity (dulaglutide)2014 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2014-09-18. Active ingredient: dulaglutide. Sponsor: Eli Lilly And Co. Application BLA125469.FDA Drugs@FDA, application BLA125469 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125469)
• Vimizim (elosulfase alfa)2014 · FDA new drug approval · BioMarin Pharmaceutical headquarters, NovatoNew drug approved by the FDA on 2014-02-14. Active ingredient: elosulfase alfa. Sponsor: Biomarin Pharm. Application BLA125460.FDA Drugs@FDA, application BLA125460 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125460)
• Zydelig (idelalisib)2014 · FDA new drug approval · Gilead Sciences headquarters, Foster CityNew drug approved by the FDA on 2014-07-23. Active ingredient: idelalisib. Sponsor: Gilead Sciences Inc. Application NDA205858.FDA Drugs@FDA, application NDA205858 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205858)
• Zykadia (ceritinib)2014 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2014-04-29. Active ingredient: ceritinib. Sponsor: Novartis. Application NDA205755.FDA Drugs@FDA, application NDA205755 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205755)
• Alecensa (alectinib hydrochloride)2015 · FDA new drug approval · Hoffmann-La Roche headquarters, BaselNew drug approved by the FDA on 2015-12-11. Active ingredient: alectinib hydrochloride. Sponsor: Hoffmann-La Roche. Application NDA208434.FDA Drugs@FDA, application NDA208434 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208434)
• Aristada (aripiprazole lauroxil)2015 · FDA new drug approval · Alkermes headquarters, DublinNew drug approved by the FDA on 2015-10-05. Active ingredient: aripiprazole lauroxil. Sponsor: Alkermes Inc. Application NDA207533.FDA Drugs@FDA, application NDA207533 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207533)
• Corlanor (ivabradine hydrochloride)2015 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2015-04-15. Active ingredient: ivabradine hydrochloride. Sponsor: Amgen Inc. Application NDA206143.FDA Drugs@FDA, application NDA206143 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206143)
• Cotellic (cobimetinib fumarate)2015 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2015-11-10. Active ingredient: cobimetinib fumarate. Sponsor: Genentech Inc. Application NDA206192.FDA Drugs@FDA, application NDA206192 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206192)
• Cresemba (isavuconazonium sulfate)2015 · FDA new drug approval · Astellas Pharma headquarters, ChūōNew drug approved by the FDA on 2015-03-06. Active ingredient: isavuconazonium sulfate. Sponsor: Astellas. Application NDA207500.FDA Drugs@FDA, application NDA207500 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207500)
• Daklinza (daclatasvir dihydrochloride)2015 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2015-07-24. Active ingredient: daclatasvir dihydrochloride. Sponsor: Bristol-Myers Squibb. Application NDA206843.FDA Drugs@FDA, application NDA206843 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206843)
• Darzalex (daratumumab)2015 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 2015-11-16. Active ingredient: daratumumab. Sponsor: Janssen Biotech. Application BLA761036.FDA Drugs@FDA, application BLA761036 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761036)
• Empliciti (elotuzumab)2015 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2015-11-30. Active ingredient: elotuzumab. Sponsor: Bristol Myers Squibb. Application BLA761035.FDA Drugs@FDA, application BLA761035 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761035)
• Ibrance (palbociclib)2015 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2015-02-03. Active ingredient: palbociclib. Sponsor: Pfizer. Application NDA207103.FDA Drugs@FDA, application NDA207103 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207103)
• Kanuma (sebelipase alfa)2015 · FDA new drug approval · Alexion Pharmaceuticals headquarters, CheshireNew drug approved by the FDA on 2015-12-08. Active ingredient: sebelipase alfa. Sponsor: Alexion Pharm. Application BLA125561.FDA Drugs@FDA, application BLA125561 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125561)
• Kengreal (cangrelor)2015 · FDA new drug approval · Chiesi Farmaceutici S.p.A. headquarters, ParmaNew drug approved by the FDA on 2015-06-22. Active ingredient: cangrelor. Sponsor: Chiesi. Application NDA204958.FDA Drugs@FDA, application NDA204958 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204958)
• Kybella (deoxycholic acid)2015 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2015-04-29. Active ingredient: deoxycholic acid. Sponsor: Abbvie. Application NDA206333.FDA Drugs@FDA, application NDA206333 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206333)
• Lenvima (lenvatinib mesylate)2015 · FDA new drug approval · Eisai headquarters, TokyoNew drug approved by the FDA on 2015-02-13. Active ingredient: lenvatinib mesylate. Sponsor: Eisai Inc. Application NDA206947.FDA Drugs@FDA, application NDA206947 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206947)
• Nucala (mepolizumab)2015 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 2015-11-04. Active ingredient: mepolizumab. Sponsor: Glaxosmithkline Llc. Application BLA125526.FDA Drugs@FDA, application BLA125526 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125526)
• Odomzo (sonidegib phosphate)2015 · FDA new drug approval · Sun Pharmaceutical headquarters, MumbaiNew drug approved by the FDA on 2015-07-24. Active ingredient: sonidegib phosphate. Sponsor: Sun Pharm. Application NDA205266.FDA Drugs@FDA, application NDA205266 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205266)
• Portrazza (necitumumab)2015 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2015-11-24. Active ingredient: necitumumab. Sponsor: Eli Lilly Co. Application BLA125547.FDA Drugs@FDA, application BLA125547 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125547)
• Praluent (alirocumab)2015 · FDA new drug approval · Regeneron Pharmaceuticals headquarters, EastviewNew drug approved by the FDA on 2015-07-24. Active ingredient: alirocumab. Sponsor: Regeneron Pharmaceuticals. Application BLA125559.FDA Drugs@FDA, application BLA125559 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125559)
• Praxbind (idarucizumab)2015 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 2015-10-16. Active ingredient: idarucizumab. Sponsor: Boehringer Ingelheim. Application BLA761025.FDA Drugs@FDA, application BLA761025 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761025)
• Repatha (evolocumab)2015 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2015-08-27. Active ingredient: evolocumab. Sponsor: Amgen Inc. Application BLA125522.FDA Drugs@FDA, application BLA125522 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125522)
• Rexulti (brexpiprazole)2015 · FDA new drug approval · Otsuka Pharmaceutical headquarters, ChiyodaNew drug approved by the FDA on 2015-07-10. Active ingredient: brexpiprazole. Sponsor: Otsuka. Application NDA205422.FDA Drugs@FDA, application NDA205422 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205422)
• Savaysa (edoxaban tosylate)2015 · FDA new drug approval · Daiichi Sankyo headquarters, ChūōNew drug approved by the FDA on 2015-01-08. Active ingredient: edoxaban tosylate. Sponsor: Daiichi Sankyo Inc. Application NDA206316.FDA Drugs@FDA, application NDA206316 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206316)
• Strensiq (asfotase alfa)2015 · FDA new drug approval · Alexion Pharmaceuticals headquarters, CheshireNew drug approved by the FDA on 2015-10-23. Active ingredient: asfotase alfa. Sponsor: Alexion Pharm. Application BLA125513.FDA Drugs@FDA, application BLA125513 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125513)
• Tagrisso (osimertinib mesylate)2015 · FDA new drug approval · AstraZeneca headquarters, CambridgeNew drug approved by the FDA on 2015-11-13. Active ingredient: osimertinib mesylate. Sponsor: Astrazeneca. Application NDA208065.FDA Drugs@FDA, application NDA208065 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208065)
• Tresiba (insulin degludec)2015 · FDA new drug approval · Novo headquarters, BagsværdNew drug approved by the FDA on 2015-09-25. Active ingredient: insulin degludec. Sponsor: Novo. Application BLA203314.FDA Drugs@FDA, application BLA203314 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203314)
• Unituxin (dinutuximab)2015 · FDA new drug approval · United Therapeutics headquarters, Silver SpringNew drug approved by the FDA on 2015-03-10. Active ingredient: dinutuximab. Sponsor: United Therap. Application BLA125516.FDA Drugs@FDA, application BLA125516 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125516)
• Uptravi (selexipag)2015 · FDA new drug approval · Actelion (United States) headquarters, San FranciscoNew drug approved by the FDA on 2015-12-21. Active ingredient: selexipag. Sponsor: Actelion. Application NDA207947.FDA Drugs@FDA, application NDA207947 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207947)
• Viberzi (eluxadoline)2015 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2015-05-27. Active ingredient: eluxadoline. Sponsor: Abbvie. Application NDA206940.FDA Drugs@FDA, application NDA206940 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206940)
• Vraylar (cariprazine hydrochloride)2015 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2015-09-17. Active ingredient: cariprazine hydrochloride. Sponsor: Abbvie. Application NDA204370.FDA Drugs@FDA, application NDA204370 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204370)
• Adlyxin (lixisenatide)2016 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 2016-07-27. Active ingredient: lixisenatide. Sponsor: Sanofi-Aventis Us. Application BLA208471.FDA Drugs@FDA, application BLA208471 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208471)
• Anthim (obiltoxaximab)2016 · FDA new drug approval · Elusys Therapeutics headquarters, MorristownNew drug approved by the FDA on 2016-03-18. Active ingredient: obiltoxaximab. Sponsor: Elusys Therapeutics Inc. Application BLA125509.FDA Drugs@FDA, application BLA125509 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125509)
• Briviact (brivaracetam)2016 · FDA new drug approval · UCB headquarters, Brussels metropolitan areaNew drug approved by the FDA on 2016-02-18. Active ingredient: brivaracetam. Sponsor: Ucb Inc. Application NDA205836.FDA Drugs@FDA, application NDA205836 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205836)
• Lartruvo (olaratumab)2016 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2016-10-19. Active ingredient: olaratumab. Sponsor: Eli Lilly And Co. Application BLA761038.FDA Drugs@FDA, application BLA761038 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761038)
• Netspot (gallium dotatate ga-68)2016 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2016-06-01. Active ingredient: gallium dotatate ga-68. Sponsor: Novartis. Application NDA208547.FDA Drugs@FDA, application NDA208547 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208547)
• Spinraza (nusinersen sodium)2016 · FDA new drug approval · Biogen headquarters, CambridgeNew drug approved by the FDA on 2016-12-23. Active ingredient: nusinersen sodium. Sponsor: Biogen. Application NDA209531.FDA Drugs@FDA, application NDA209531 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209531)
• Taltz (ixekizumab)2016 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2016-03-22. Active ingredient: ixekizumab. Sponsor: Eli Lilly And Co. Application BLA125521.FDA Drugs@FDA, application BLA125521 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125521)
• Tecentriq (atezolizumab)2016 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2016-05-18. Active ingredient: atezolizumab. Sponsor: Genentech Inc. Application BLA761034.FDA Drugs@FDA, application BLA761034 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761034)
• Venclexta (venetoclax)2016 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2016-04-11. Active ingredient: venetoclax. Sponsor: Abbvie. Application NDA208573.FDA Drugs@FDA, application NDA208573 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208573)
• Xiidra (lifitegrast)2016 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 2016-07-11. Active ingredient: lifitegrast. Sponsor: Bausch And Lomb Inc. Application NDA208073.FDA Drugs@FDA, application NDA208073 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208073)
• Zinbryta (daclizumab)2016 · FDA new drug approval · Biogen headquarters, CambridgeNew drug approved by the FDA on 2016-05-27. Active ingredient: daclizumab. Sponsor: Biogen. Application BLA761029.FDA Drugs@FDA, application BLA761029 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761029)
• Zinplava (bezlotoxumab)2016 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2016-10-21. Active ingredient: bezlotoxumab. Sponsor: Merck Sharp Dohme. Application BLA761046.FDA Drugs@FDA, application BLA761046 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761046)
• Aliqopa (copanlisib dihydrochloride)2017 · FDA new drug approval · Bayer HealthCare headquarters, LeverkusenNew drug approved by the FDA on 2017-09-14. Active ingredient: copanlisib dihydrochloride. Sponsor: Bayer Healthcare. Application NDA209936.FDA Drugs@FDA, application NDA209936 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209936)
• Austedo (deutetrabenazine)2017 · FDA new drug approval · Teva Pharmaceutical Industries Ltd. headquarters, Ramat HaHayalNew drug approved by the FDA on 2017-04-03. Active ingredient: deutetrabenazine. Sponsor: Teva Branded Pharm. Application NDA208082.FDA Drugs@FDA, application NDA208082 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208082)
• Bavencio (avelumab)2017 · FDA new drug approval · Merck KGaA headquarters, DarmstadtNew drug approved by the FDA on 2017-03-23. Active ingredient: avelumab. Sponsor: Emd Serono Inc. Application BLA761049.FDA Drugs@FDA, application BLA761049 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761049)
• Brineura (cerliponase alfa)2017 · FDA new drug approval · BioMarin Pharmaceutical headquarters, NovatoNew drug approved by the FDA on 2017-04-27. Active ingredient: cerliponase alfa. Sponsor: Biomarin Pharm. Application BLA761052.FDA Drugs@FDA, application BLA761052 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761052)
• Calquence (acalabrutinib)2017 · FDA new drug approval · AstraZeneca headquarters, CambridgeNew drug approved by the FDA on 2017-10-31. Active ingredient: acalabrutinib. Sponsor: Astrazeneca. Application NDA210259.FDA Drugs@FDA, application NDA210259 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210259)
• Dupixent (dupilumab)2017 · FDA new drug approval · Regeneron Pharmaceuticals headquarters, EastviewNew drug approved by the FDA on 2017-03-28. Active ingredient: dupilumab. Sponsor: Regeneron Pharmaceuticals. Application BLA761055.FDA Drugs@FDA, application BLA761055 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761055)
• Emflaza (deflazacort)2017 · FDA new drug approval · PTC Therapeutics headquarters, South PlainfieldNew drug approved by the FDA on 2017-02-09. Active ingredient: deflazacort. Sponsor: Ptc Therap. Application NDA208684.FDA Drugs@FDA, application NDA208684 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208684)
• Emflaza (deflazacort)2017 · FDA new drug approval · PTC Therapeutics headquarters, South PlainfieldNew drug approved by the FDA on 2017-02-09. Active ingredient: deflazacort. Sponsor: Ptc Therap. Application NDA208685.FDA Drugs@FDA, application NDA208685 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208685)
• Fasenra (benralizumab)2017 · FDA new drug approval · AstraZeneca AB headquarters, SödertäljeNew drug approved by the FDA on 2017-11-14. Active ingredient: benralizumab. Sponsor: Astrazeneca Ab. Application BLA761070.FDA Drugs@FDA, application BLA761070 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761070)
• Hemlibra (emicizumab)2017 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2017-11-16. Active ingredient: emicizumab. Sponsor: Genentech Inc. Application BLA761083.FDA Drugs@FDA, application BLA761083 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761083)
• Idhifa (enasidenib mesylate)2017 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2017-08-01. Active ingredient: enasidenib mesylate. Sponsor: Bristol Myers Squibb. Application NDA209606.FDA Drugs@FDA, application NDA209606 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209606)
• Ingrezza (valbenazine tosylate)2017 · FDA new drug approval · Neurocrine Biosciences headquarters, San DiegoNew drug approved by the FDA on 2017-04-11. Active ingredient: valbenazine tosylate. Sponsor: Neurocrine. Application NDA209241.FDA Drugs@FDA, application NDA209241 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209241)
• Kevzara (sarilumab)2017 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 2017-05-22. Active ingredient: sarilumab. Sponsor: Sanofi Synthelabo. Application BLA761037.FDA Drugs@FDA, application BLA761037 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761037)
• Kisqali (ribociclib succinate)2017 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2017-03-13. Active ingredient: ribociclib succinate. Sponsor: Novartis. Application NDA209092.FDA Drugs@FDA, application NDA209092 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209092)
• Macrilen (macimorelin acetate)2017 · FDA new drug approval · Aeterna Zentaris headquarters, FrankfurtNew drug approved by the FDA on 2017-12-20. Active ingredient: macimorelin acetate. Sponsor: Aeterna Zentaris. Application NDA205598.FDA Drugs@FDA, application NDA205598 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205598)
• Mepsevii (vestronidase alfa-vjbk)2017 · FDA new drug approval · Ultragenyx Pharmaceutical headquarters, NovatoNew drug approved by the FDA on 2017-11-15. Active ingredient: vestronidase alfa-vjbk. Sponsor: Ultragenyx Pharm Inc. Application BLA761047.FDA Drugs@FDA, application BLA761047 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761047)
• Nerlynx (neratinib maleate)2017 · FDA new drug approval · Puma Biotechnology headquarters, Los AngelesNew drug approved by the FDA on 2017-07-17. Active ingredient: neratinib maleate. Sponsor: Puma Biotech. Application NDA208051.FDA Drugs@FDA, application NDA208051 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208051)
• Ocrevus (ocrelizumab)2017 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2017-03-28. Active ingredient: ocrelizumab. Sponsor: Genentech Inc. Application BLA761053.FDA Drugs@FDA, application BLA761053 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761053)
• Ozempic (semaglutide)2017 · FDA new drug approval · Novo headquarters, BagsværdNew drug approved by the FDA on 2017-12-05. Active ingredient: semaglutide. Sponsor: Novo. Application NDA209637.FDA Drugs@FDA, application NDA209637 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209637)
• Prevymis (letermovir)2017 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2017-11-08. Active ingredient: letermovir. Sponsor: Merck Sharp Dohme. Application NDA209939.FDA Drugs@FDA, application NDA209939 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209939)
• Radicava (edaravone)2017 · FDA new drug approval · Shionogi headquarters, Chūō-kuNew drug approved by the FDA on 2017-05-05. Active ingredient: edaravone. Sponsor: Shionogi. Application NDA209176.FDA Drugs@FDA, application NDA209176 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209176)
• Rhopressa (netarsudil mesylate)2017 · FDA new drug approval · Alcon headquarters, GenevaNew drug approved by the FDA on 2017-12-18. Active ingredient: netarsudil mesylate. Sponsor: Alcon Labs Inc. Application NDA208254.FDA Drugs@FDA, application NDA208254 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208254)
• Rydapt (midostaurin)2017 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2017-04-28. Active ingredient: midostaurin. Sponsor: Novartis. Application NDA207997.FDA Drugs@FDA, application NDA207997 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207997)
• Symproic (naldemedine tosylate)2017 · FDA new drug approval · BioDelivery Sciences International headquarters, RaleighNew drug approved by the FDA on 2017-03-23. Active ingredient: naldemedine tosylate. Sponsor: Bdsi. Application NDA208854.FDA Drugs@FDA, application NDA208854 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208854)
• Tremfya (guselkumab)2017 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 2017-07-13. Active ingredient: guselkumab. Sponsor: Janssen Biotech. Application BLA761061.FDA Drugs@FDA, application BLA761061 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761061)
• Tymlos (abaloparatide)2017 · FDA new drug approval · Radius headquarters, SunnyvaleNew drug approved by the FDA on 2017-04-28. Active ingredient: abaloparatide. Sponsor: Radius. Application NDA208743.FDA Drugs@FDA, application NDA208743 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208743)
• Verzenio (abemaciclib)2017 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2017-09-28. Active ingredient: abemaciclib. Sponsor: Eli Lilly And Co. Application NDA208716.FDA Drugs@FDA, application NDA208716 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208716)
• Vyzulta (latanoprostene bunod)2017 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 2017-11-02. Active ingredient: latanoprostene bunod. Sponsor: Bausch And Lomb. Application NDA207795.FDA Drugs@FDA, application NDA207795 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207795)
• Xadago (safinamide mesylate)2017 · FDA new drug approval · McDonnell Douglas headquarters, St. LouisNew drug approved by the FDA on 2017-03-21. Active ingredient: safinamide mesylate. Sponsor: Mdd Us. Application NDA207145.FDA Drugs@FDA, application NDA207145 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207145)
• Zejula (niraparib tosylate)2017 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 2017-03-27. Active ingredient: niraparib tosylate. Sponsor: Glaxosmithkline. Application NDA208447.FDA Drugs@FDA, application NDA208447 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208447)
• Aimovig (erenumab-aooe)2018 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2018-05-17. Active ingredient: erenumab-aooe. Sponsor: Amgen Inc. Application BLA761077.FDA Drugs@FDA, application BLA761077 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761077)
• Asparlas (calaspargase pegol-mknl)2018 · FDA new drug approval · Laboratoires Servier headquarters, SuresnesNew drug approved by the FDA on 2018-12-20. Active ingredient: calaspargase pegol-mknl. Sponsor: Servier Pharma Llc. Application BLA761102.FDA Drugs@FDA, application BLA761102 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761102)
• Braftovi (encorafenib)2018 · FDA new drug approval · Array BioPharma headquarters, BoulderNew drug approved by the FDA on 2018-06-27. Active ingredient: encorafenib. Sponsor: Array Biopharma Inc. Application NDA210496.FDA Drugs@FDA, application NDA210496 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210496)
• Crysvita (burosumab-twza)2018 · FDA new drug approval · Kyowa Kirin headquarters, Otemachi Financial City Grand CubeNew drug approved by the FDA on 2018-04-17. Active ingredient: burosumab-twza. Sponsor: Kyowa Kirin. Application BLA761068.FDA Drugs@FDA, application BLA761068 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761068)
• Daurismo (glasdegib maleate)2018 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2018-11-21. Active ingredient: glasdegib maleate. Sponsor: Pfizer. Application NDA210656.FDA Drugs@FDA, application NDA210656 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210656)
• Diacomit (stiripentol)2018 · FDA new drug approval · Biocodex headquarters, GentillyNew drug approved by the FDA on 2018-08-20. Active ingredient: stiripentol. Sponsor: Biocodex Sa. Application NDA206709.FDA Drugs@FDA, application NDA206709 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206709)
• Emgality (galcanezumab-gnlm)2018 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2018-09-27. Active ingredient: galcanezumab-gnlm. Sponsor: Eli Lilly And Co. Application BLA761063.FDA Drugs@FDA, application BLA761063 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761063)
• Erleada (apalutamide)2018 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 2018-02-14. Active ingredient: apalutamide. Sponsor: Janssen Biotech. Application NDA210951.FDA Drugs@FDA, application NDA210951 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210951)
• Galafold (migalastat hydrochloride)2018 · FDA new drug approval · Amicus Therapeutics headquarters, CranburyNew drug approved by the FDA on 2018-08-10. Active ingredient: migalastat hydrochloride. Sponsor: Amicus Therap Us. Application NDA208623.FDA Drugs@FDA, application NDA208623 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208623)
• Krintafel (tafenoquine succinate)2018 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 2018-07-20. Active ingredient: tafenoquine succinate. Sponsor: Glaxosmithkline. Application NDA210795.FDA Drugs@FDA, application NDA210795 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210795)
• Libtayo (cemiplimab-rwlc)2018 · FDA new drug approval · Regeneron Pharmaceuticals headquarters, EastviewNew drug approved by the FDA on 2018-09-28. Active ingredient: cemiplimab-rwlc. Sponsor: Regeneron Pharmaceuticals. Application BLA761097.FDA Drugs@FDA, application BLA761097 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761097)
• Lokelma (sodium zirconium cyclosilicate)2018 · FDA new drug approval · AstraZeneca headquarters, CambridgeNew drug approved by the FDA on 2018-05-18. Active ingredient: sodium zirconium cyclosilicate. Sponsor: Astrazeneca. Application NDA207078.FDA Drugs@FDA, application NDA207078 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207078)
• Lorbrena (lorlatinib)2018 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2018-11-02. Active ingredient: lorlatinib. Sponsor: Pfizer. Application NDA210868.FDA Drugs@FDA, application NDA210868 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210868)
• Mektovi (binimetinib)2018 · FDA new drug approval · Array BioPharma headquarters, BoulderNew drug approved by the FDA on 2018-06-27. Active ingredient: binimetinib. Sponsor: Array Biopharma Inc. Application NDA210498.FDA Drugs@FDA, application NDA210498 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210498)
• Moxidectin (moxidectin)2018 · FDA new drug approval · Mamoura Diversified Global Holding headquarters, Abu DhabiNew drug approved by the FDA on 2018-06-13. Active ingredient: moxidectin. Sponsor: Mdgh. Application NDA210867.FDA Drugs@FDA, application NDA210867 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210867)
• Olumiant (baricitinib)2018 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2018-05-31. Active ingredient: baricitinib. Sponsor: Eli Lilly And Co. Application NDA207924.FDA Drugs@FDA, application NDA207924 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207924)
• Orilissa (elagolix sodium)2018 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2018-07-23. Active ingredient: elagolix sodium. Sponsor: Abbvie. Application NDA210450.FDA Drugs@FDA, application NDA210450 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210450)
• Oxervate (cenegermin-bkbj)2018 · FDA new drug approval · Dompé headquarters, L'AquilaNew drug approved by the FDA on 2018-08-22. Active ingredient: cenegermin-bkbj. Sponsor: Dompe Farmaceutici. Application BLA761094.FDA Drugs@FDA, application BLA761094 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761094)
• Palynziq (pegvaliase-pqpz)2018 · FDA new drug approval · BioMarin Pharmaceutical headquarters, NovatoNew drug approved by the FDA on 2018-05-24. Active ingredient: pegvaliase-pqpz. Sponsor: Biomarin Pharm. Application BLA761079.FDA Drugs@FDA, application BLA761079 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761079)
• Pifeltro (doravirine)2018 · FDA new drug approval · MSD-Merck Sharp and Dohme Idea Inc headquarters, PragueNew drug approved by the FDA on 2018-08-30. Active ingredient: doravirine. Sponsor: Msd Merck Co. Application NDA210806.FDA Drugs@FDA, application NDA210806 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210806)
• Poteligeo (mogamulizumab-kpkc)2018 · FDA new drug approval · Kyowa Kirin headquarters, Otemachi Financial City Grand CubeNew drug approved by the FDA on 2018-08-08. Active ingredient: mogamulizumab-kpkc. Sponsor: Kyowa Kirin. Application BLA761051.FDA Drugs@FDA, application BLA761051 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761051)
• Revcovi (elapegademase-lvlr)2018 · FDA new drug approval · Chiesi Farmaceutici S.p.A. headquarters, ParmaNew drug approved by the FDA on 2018-10-05. Active ingredient: elapegademase-lvlr. Sponsor: Chiesi Usa Inc. Application BLA761092.FDA Drugs@FDA, application BLA761092 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761092)
• Seysara (sarecycline hydrochloride)2018 · FDA new drug approval · Almirall headquarters, BarcelonaNew drug approved by the FDA on 2018-10-01. Active ingredient: sarecycline hydrochloride. Sponsor: Almirall. Application NDA209521.FDA Drugs@FDA, application NDA209521 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209521)
• Takhzyro (lanadelumab-flyo)2018 · FDA new drug approval · Dyax (United States) headquarters, BurlingtonNew drug approved by the FDA on 2018-08-23. Active ingredient: lanadelumab-flyo. Sponsor: Dyax Corp.. Application BLA761090.FDA Drugs@FDA, application BLA761090 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761090)
• Talzenna (talazoparib tosylate)2018 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2018-10-16. Active ingredient: talazoparib tosylate. Sponsor: Pfizer. Application NDA211651.FDA Drugs@FDA, application NDA211651 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211651)
• Tibsovo (ivosidenib)2018 · FDA new drug approval · Laboratoires Servier headquarters, SuresnesNew drug approved by the FDA on 2018-07-20. Active ingredient: ivosidenib. Sponsor: Servier. Application NDA211192.FDA Drugs@FDA, application NDA211192 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211192)
• Tpoxx (tecovirimat)2018 · FDA new drug approval · SIGA Technologies headquarters, New York CityNew drug approved by the FDA on 2018-07-13. Active ingredient: tecovirimat. Sponsor: Siga Technologies. Application NDA208627.FDA Drugs@FDA, application NDA208627 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208627)
• Ultomiris (ravulizumab-cwvz)2018 · FDA new drug approval · Alexion Pharmaceuticals headquarters, CheshireNew drug approved by the FDA on 2018-12-21. Active ingredient: ravulizumab-cwvz. Sponsor: Alexion Pharm. Application BLA761108.FDA Drugs@FDA, application BLA761108 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761108)
• Vizimpro (dacomitinib)2018 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2018-09-27. Active ingredient: dacomitinib. Sponsor: Pfizer. Application NDA211288.FDA Drugs@FDA, application NDA211288 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211288)
• Xofluza (baloxavir marboxil)2018 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2018-10-24. Active ingredient: baloxavir marboxil. Sponsor: Genentech Inc. Application NDA210854.FDA Drugs@FDA, application NDA210854 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210854)
• Xospata (gilteritinib fumarate)2018 · FDA new drug approval · Astellas Pharma headquarters, ChūōNew drug approved by the FDA on 2018-11-28. Active ingredient: gilteritinib fumarate. Sponsor: Astellas. Application NDA211349.FDA Drugs@FDA, application NDA211349 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211349)
• Zemdri (plazomicin sulfate)2018 · FDA new drug approval · Cipla headquarters, MumbaiNew drug approved by the FDA on 2018-06-25. Active ingredient: plazomicin sulfate. Sponsor: Cipla Usa. Application NDA210303.FDA Drugs@FDA, application NDA210303 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210303)
• Aklief (trifarotene)2019 · FDA new drug approval · Galderma headquarters, ZugNew drug approved by the FDA on 2019-10-04. Active ingredient: trifarotene. Sponsor: Galderma Labs Lp. Application NDA211527.FDA Drugs@FDA, application NDA211527 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211527)
• Balversa (erdafitinib)2019 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 2019-04-12. Active ingredient: erdafitinib. Sponsor: Janssen Biotech. Application NDA212018.FDA Drugs@FDA, application NDA212018 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212018)
• Caplyta (lumateperone tosylate)2019 · FDA new drug approval · Intra Cellular Therapies (United States) headquarters, New York CityNew drug approved by the FDA on 2019-12-20. Active ingredient: lumateperone tosylate. Sponsor: Intra-Cellular. Application NDA209500.FDA Drugs@FDA, application NDA209500 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209500)
• Dayvigo (lemborexant)2019 · FDA new drug approval · Eisai headquarters, TokyoNew drug approved by the FDA on 2019-12-20. Active ingredient: lemborexant. Sponsor: Eisai Inc. Application NDA212028.FDA Drugs@FDA, application NDA212028 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212028)
• Egaten (triclabendazole)2019 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2019-02-13. Active ingredient: triclabendazole. Sponsor: Novartis. Application NDA208711.FDA Drugs@FDA, application NDA208711 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208711)
• Enhertu (fam-trastuzumab deruxtecan-nxki)2019 · FDA new drug approval · Daiichi Sankyo headquarters, ChūōNew drug approved by the FDA on 2019-12-20. Active ingredient: fam-trastuzumab deruxtecan-nxki. Sponsor: Daiichi Sankyo. Application BLA761139.FDA Drugs@FDA, application BLA761139 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761139)
• Evenity (romosozumab-aqqg)2019 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2019-04-09. Active ingredient: romosozumab-aqqg. Sponsor: Amgen Inc. Application BLA761062.FDA Drugs@FDA, application BLA761062 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761062)
• Fetroja (cefiderocol sulfate tosylate)2019 · FDA new drug approval · Shionogi headquarters, Chūō-kuNew drug approved by the FDA on 2019-11-14. Active ingredient: cefiderocol sulfate tosylate. Sponsor: Shionogi. Application NDA209445.FDA Drugs@FDA, application NDA209445 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209445)
• Ibsrela (tenapanor hydrochloride)2019 · FDA new drug approval · Ardelyx (United States) headquarters, FremontNew drug approved by the FDA on 2019-09-12. Active ingredient: tenapanor hydrochloride. Sponsor: Ardelyx Inc. Application NDA211801.FDA Drugs@FDA, application NDA211801 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211801)
• Inrebic (fedratinib hydrochloride)2019 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2019-08-16. Active ingredient: fedratinib hydrochloride. Sponsor: Bristol-Myers. Application NDA212327.FDA Drugs@FDA, application NDA212327 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212327)
• Mayzent (siponimod)2019 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2019-03-26. Active ingredient: siponimod. Sponsor: Novartis. Application NDA209884.FDA Drugs@FDA, application NDA209884 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209884)
• Nourianz (istradefylline)2019 · FDA new drug approval · Kyowa Kirin headquarters, Otemachi Financial City Grand CubeNew drug approved by the FDA on 2019-08-27. Active ingredient: istradefylline. Sponsor: Kyowa Kirin. Application NDA022075.FDA Drugs@FDA, application NDA022075 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022075)
• Nubeqa (darolutamide)2019 · FDA new drug approval · Bayer HealthCare headquarters, LeverkusenNew drug approved by the FDA on 2019-07-30. Active ingredient: darolutamide. Sponsor: Bayer Healthcare. Application NDA212099.FDA Drugs@FDA, application NDA212099 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212099)
• Padcev (enfortumab vedotin-ejfv)2019 · FDA new drug approval · Astellas Pharma headquarters, ChūōNew drug approved by the FDA on 2019-12-18. Active ingredient: enfortumab vedotin-ejfv. Sponsor: Astellas. Application BLA761137.FDA Drugs@FDA, application BLA761137 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761137)
• Piqray (alpelisib)2019 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2019-05-24. Active ingredient: alpelisib. Sponsor: Novartis. Application NDA212526.FDA Drugs@FDA, application NDA212526 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212526)
• Polivy (polatuzumab vedotin-piiq)2019 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2019-06-10. Active ingredient: polatuzumab vedotin-piiq. Sponsor: Genentech. Application BLA761121.FDA Drugs@FDA, application BLA761121 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761121)

Pages: 1 2 3