Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved 7 new drug or biologic applications and 16 efficacy supplements (new uses for approved drugs) in January 2025, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 7
Jan 16: the FDA approved Brynovin (sitagliptin hydrochloride oral), Azurity, NDA219122 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Jan 17: the FDA approved Datroway (datopotamab deruxtecan), Daiichi Sankyo Inc, BLA761394 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jan 21: the FDA approved Grafapex (treosulfan), Medexus, NDA214759 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jan 24: the FDA approved Avtozma (tocilizumab), Celltrion Inc, BLA761420 ORIG-1. FDA letter.
Jan 28: the FDA approved Inzirqo (hydrochlorothiazide), Novitium Pharma, NDA219141 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Jan 30: the FDA approved Journavx (suzetrigine), Vertex Pharms Inc, NDA219209 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jan 30: the FDA approved Symbravo (meloxicam, rizatriptan), Axsome, NDA215431 ORIG-1 (Type 4 - New Combination). FDA letter.
New uses for approved drugs (efficacy supplements) · 16
Jan 15: the FDA approved an efficacy supplement for Omvoh (mirikizumab-mrkz), Eli Lilly And Co, BLA761279 SUPPL-2. FDA letter.
Jan 15: the FDA approved an efficacy supplement for Omvoh (mirikizumab-mrkz), Eli Lilly And Co, BLA761279 SUPPL-3. FDA letter.
Jan 16: the FDA approved an efficacy supplement for Calquence (acalabrutinib), Astrazeneca, NDA210259 SUPPL-11. FDA letter.
Jan 16: the FDA approved an efficacy supplement for Calquence (acalabrutinib), Astrazeneca, NDA216387 SUPPL-5. FDA letter.
Jan 16: the FDA approved an efficacy supplement for Lumakras (sotorasib), Amgen Inc, NDA214665 SUPPL-9. FDA letter.
Jan 16: the FDA approved an efficacy supplement for Vectibix (panitumumab), Amgen, BLA125147 SUPPL-213. FDA letter.
Jan 17: the FDA approved an efficacy supplement for Spravato (esketamine hydrochloride), Janssen Pharms, NDA211243 SUPPL-16. FDA letter.
Jan 23: the FDA approved an efficacy supplement for Darzalex (daratumumab), Janssen Biotech, BLA761036 SUPPL-51. FDA letter.
Jan 24: the FDA approved an efficacy supplement for Leqembi (lecanemab), Eisai Inc, BLA761269 SUPPL-5. FDA letter.
Jan 27: the FDA approved an efficacy supplement for Cyramza (ramucirumab), Eli Lilly And Co, BLA125477 SUPPL-48. FDA letter.
Jan 27: the FDA approved an efficacy supplement for Enhertu (fam-trastuzumab deruxtecan-nxki), Daiichi Sankyo, BLA761139 SUPPL-32. FDA letter.
Jan 28: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-172. FDA letter.
Jan 28: the FDA approved an efficacy supplement for Ozempic (semaglutide), Novo, NDA209637 SUPPL-25. FDA letter.
Jan 28: the FDA approved an efficacy supplement for Yervoy (ipilimumab), Bristol Myers Squibb, BLA125377 SUPPL-132. FDA letter.
Jan 29: the FDA approved an efficacy supplement for Lenvima (lenvatinib), Eisai Inc, NDA206947 SUPPL-33. FDA letter.
Jan 31: the FDA approved an efficacy supplement for Paxlovid (nirmatrelvir and ritonavir), Pfizer, NDA217188 SUPPL-8. 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. February 2025 → · all months · PDUFA decisions this month · decisions we tracked in 2025