Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved 15 new drug or biologic applications and 14 efficacy supplements (new uses for approved drugs) in February 2025, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 15
Feb 2: the FDA approved Carbon Dioxide, Welders Supply Company Of Louisville Inc, NDA220266 ORIG-1 (Medical Gas). FDA letter.
Feb 3: the FDA approved Onapgo (apomorphine hydrochloride), Mdd Us, NDA214056 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Feb 7: the FDA approved Emblaveo (aztreonam and avibactam), Abbvie, NDA217906 ORIG-1 (Type 4 - New Combination). FDA letter.
Feb 11: the FDA approved Evrysdi (risdiplam), Genentech Inc, NDA219285 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Feb 11: the FDA approved Gomekli (mirdametinib), Springworks, NDA219379 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Feb 11: the FDA approved Gomekli (mirdametinib), Springworks, NDA219389 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Feb 13: the FDA approved Ospomyv (denosumab), Samsung Bioepis Co Ltd, BLA761392 ORIG-1. FDA letter.
Feb 14: the FDA approved Merilog (insulin aspart-szjj), Sanofi-Aventis U.S. Llc, BLA761325 ORIG-1. FDA letter.
Feb 14: the FDA approved Romvimza (vimseltinib), Deciphera Pharms, NDA219304 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Feb 19: the FDA approved Nilotinib, Cipla, NDA218922 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Feb 21: the FDA approved Ctexli (chenodiol), Mirum, NDA219488 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Feb 21: the FDA approved Diltiazem Hydrochloride In Sodium Chloride (diltiazem hydrochloride), Hq Spclt Pharma, NDA218038 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Feb 24: the FDA approved Miudella (copper), Sebela Womens Hlth, NDA218201 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Feb 28: the FDA approved Epinephrine, Baxter Hlthcare Corp, NDA218475 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Feb 28: the FDA approved Stoboclo (denosumab-bmwo), Celltrion Inc, BLA761404 ORIG-1. FDA letter.
New uses for approved drugs (efficacy supplements) · 14
Feb 3: the FDA approved an efficacy supplement for Susvimo (ranibizumab), Genentech Inc, BLA761197 SUPPL-6. FDA letter.
Feb 7: the FDA approved an efficacy supplement for Moxidectin, Mdgh, NDA210867 SUPPL-6. FDA letter.
Feb 11: the FDA approved an efficacy supplement for Adcetris (brentuximab vedotin), Seattle Genetics, BLA125388 SUPPL-108. FDA letter.
Feb 12: the FDA approved an efficacy supplement for Izervay (avacincaptad pegol), Astellas, NDA217225 SUPPL-1. FDA letter.
Feb 19: the FDA approved an efficacy supplement for Odefsey (emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide), Gilead Sciences Inc, NDA208351 SUPPL-15. FDA letter.
Feb 19: the FDA approved an efficacy supplement for Odefsey (emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide), Gilead Sciences Inc, NDA208351 SUPPL-14. FDA letter.
Feb 21: the FDA approved an efficacy supplement for Sublocade (buprenorphine), Indivior, NDA209819 SUPPL-31. FDA letter.
Feb 21: the FDA approved an efficacy supplement for Xeljanz (tofacitinib), Pfizer, NDA213082 SUPPL-10. FDA letter.
Feb 21: the FDA approved an efficacy supplement for Xeljanz (tofacitinib), Pf Prism Cv, NDA203214 SUPPL-38. FDA letter.
Feb 21: the FDA approved an efficacy supplement for Xeljanz Xr (tofacitinib), Pfizer, NDA208246 SUPPL-25. FDA letter.
Feb 28: the FDA approved an efficacy supplement for Imfinzi (durvalumab), Astrazeneca Uk Ltd, BLA761069 SUPPL-51. FDA letter.
Feb 28: the FDA approved an efficacy supplement for Opsumit (macitentan), Actelion, NDA204410 SUPPL-29. FDA letter.
Feb 28: the FDA approved an efficacy supplement for Soliris (eculizumab), Alexion Pharm, BLA125166 SUPPL-448. FDA letter.
Feb 28: the FDA approved an efficacy supplement for Tnkase (tenecteplase), Genentech, BLA103909 SUPPL-5197. 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 2025 · March 2025 → · all months · PDUFA decisions this month · decisions we tracked in 2025