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The FDA approved 13 new drug or biologic applications and 22 efficacy supplements (new uses for approved drugs) in February 2026, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 13
Feb 2: the FDA approved Air, General Air Service & Supply Company, NDA221287 ORIG-1. FDA letter.
Feb 3: the FDA approved Vykoura (leucovorin calcium), Avyxa Holdings, NDA220406 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Feb 12: the FDA approved Adquey (difamilast), Acrotech Biopharma, NDA219474 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Feb 13: the FDA approved Avopef (etoposide), Avyxa Holdings, NDA220200 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Feb 13: the FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), Janssen Biotech, BLA761484 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Feb 17: the FDA approved Medical Air, Usp, Industrial Welding Supply Co Of Harvey Inc, NDA221337 ORIG-1. FDA letter.
Feb 20: the FDA approved Bysanti (milsaperidone), Vanda Pharms Inc, NDA220358 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Feb 20: the FDA approved Favlyxa (fluorouracil), Avyxa Holdings, NDA220201 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Feb 23: the FDA approved Loargys (pegzilarginase-nbln), Immedica Pharma Ab, BLA761211 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Feb 25: the FDA approved Desmoda (desmopressin acetate oral solution), Eton, NDA219873 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Feb 27: the FDA approved Duloxetine, Almatica, NDA219131 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Feb 27: the FDA approved Prezcobix Ped (darunavir ethanolate and cobicistat), Janssen Prods, NDA220092 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Feb 27: the FDA approved Yuviwel (navepegritide), Ascendis, NDA219164 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
New uses for approved drugs (efficacy supplements) · 22
Feb 10: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-186. FDA letter.
Feb 10: the FDA approved an efficacy supplement for Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), Merck Sharp Dohme, BLA761467 SUPPL-2. FDA letter.
Feb 12: the FDA approved an efficacy supplement for Leqvio (inclisiran), Novartis, NDA214012 SUPPL-18. FDA letter.
Feb 12: the FDA approved an efficacy supplement for Leqvio (inclisiran), Novartis, NDA214012 SUPPL-17. FDA letter.
Feb 13: the FDA approved an efficacy supplement for Cefazolin, Hq Spclt Pharma, NDA211413 SUPPL-3. FDA letter.
Feb 13: the FDA approved an efficacy supplement for Rapiblyk (landiolol), Aop Hlth Us, NDA217202 SUPPL-1. FDA letter.
Feb 13: the FDA approved an efficacy supplement for Wakix (pitolisant hydrochloride), Harmony, NDA211150 SUPPL-6. FDA letter.
Feb 19: the FDA approved an efficacy supplement for Calquence (acalabrutinib), Astrazeneca, NDA210259 SUPPL-12. FDA letter.
Feb 19: the FDA approved an efficacy supplement for Calquence (acalabrutinib), Astrazeneca, NDA216387 SUPPL-6. FDA letter.
Feb 19: the FDA approved an efficacy supplement for Venclexta (venetoclax), Abbvie, NDA208573 SUPPL-31. FDA letter.
Feb 20: the FDA approved an efficacy supplement for Vueway (gadopiclenol), Guerbet, NDA216986 SUPPL-9. FDA letter.
Feb 23: the FDA approved an efficacy supplement for Dupixent (dupilumab), Regeneron Pharmaceuticals, BLA761055 SUPPL-75. FDA letter.
Feb 24: the FDA approved an efficacy supplement for Braftovi (encorafenib), Array Biopharma Inc, NDA210496 SUPPL-19. FDA letter.
Feb 24: the FDA approved an efficacy supplement for Braftovi (encorafenib), Array Biopharma Inc, NDA210496 SUPPL-21. FDA letter.
Feb 25: the FDA approved an efficacy supplement for Juxtapid (lomitapide mesylate), Chiesi, NDA203858 SUPPL-27. FDA letter.
Feb 26: the FDA approved an efficacy supplement for Hernexeos (zongertinib), Boehringer Ingelheim, NDA219042 SUPPL-1. FDA letter.
Feb 26: the FDA approved an efficacy supplement for Rizafilm (rizatriptan benzoate), Gensco, NDA205394 SUPPL-5. FDA letter.
Feb 27: the FDA approved an efficacy supplement for Palynziq (pegvaliase-pqpz), Biomarin Pharm, BLA761079 SUPPL-31. FDA letter.
Feb 27: the FDA approved an efficacy supplement for Prezcobix (darunavir ethanolate and cobicistat), Janssen Prods, NDA205395 SUPPL-29. FDA letter.
Feb 27: the FDA approved an efficacy supplement for Sogroya (somapacitan-beco), Novo Nordisk Inc, BLA761156 SUPPL-15. FDA letter.
Feb 27: the FDA approved an efficacy supplement for Sogroya (somapacitan-beco), Novo Nordisk Inc, BLA761156 SUPPL-14. FDA letter.
Feb 27: the FDA approved an efficacy supplement for Sogroya (somapacitan-beco), Novo Nordisk Inc, BLA761156 SUPPL-12. FDA letter.
Source: openFDA drugsfda (the Drugs@FDA data), read 2026-11-12. openFDA trails Drugs@FDA by about a week, so the latest days of a month can be missing until the next read. Generic approvals (ANDAs), labeling-only and manufacturing supplements are not listed. ← January 2026 · March 2026 → · all months · PDUFA decisions this month · decisions we tracked in 2026