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 13 efficacy supplements (new uses for approved drugs) in September 2025, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 15
Sep 9: the FDA approved Inlexzo (gemcitabine intravesical), Janssen Biotech, NDA219683 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Sep 9: the FDA approved Zolymbus (bimatoprost), Thea Pharma, NDA217307 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Sep 10: the FDA approved Koselugo (selumetinib), Astrazeneca, NDA219943 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Sep 12: the FDA approved Enbumyst (bumetanide), Corstasis Therap, NDA219500 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Sep 16: the FDA approved Bosaya (denosumab-kyqq), Biocon Biologics Inc, BLA761436 ORIG-1. FDA letter.
Sep 16: the FDA approved Subvenite (lamotrigine), Owp Pharms, NDA218879 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Sep 19: the FDA approved Forzinity (elamipretide hydrochloride), Stealth Biotheraps, NDA215244 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Sep 19: the FDA approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), Merck Sharp Dohme, BLA761467 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Sep 19: the FDA approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), Merck Sharp Dohme, BLA761467 ORIG-2 (Efficacy). FDA letter.
Sep 24: the FDA approved Bondlido (lidocaine), Medrx Usa, NDA215029 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Sep 25: the FDA approved Inluriyo (imlunestrant), Eli Lilly And Co, NDA218881 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Sep 25: the FDA approved Palsonify (paltusotine), Crinetics, NDA219070 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Sep 26: the FDA approved Clotic (Clotrimazole) Otic Solution (clotrimazole), Carwin Pharm Assoc, NDA217628 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Sep 26: the FDA approved Enoby (denosumab-qbde), Hikma Pharmaceuticals Usa Inc, BLA761439 ORIG-1. FDA letter.
Sep 30: the FDA approved Rhapsido (remibrutinib), Novartis, NDA218436 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
New uses for approved drugs (efficacy supplements) · 13
Sep 3: the FDA approved an efficacy supplement for Skyrizi (risankizumab-rzaa), Abbvie Inc, BLA761105 SUPPL-39. FDA letter.
Sep 3: the FDA approved an efficacy supplement for Skyrizi (risankizumab-rzaa), Abbvie Inc, BLA761262 SUPPL-11. FDA letter.
Sep 3: the FDA approved an efficacy supplement for Vigafyde (vigabatrin), Pyros Pharms, NDA217684 SUPPL-2. FDA letter.
Sep 10: the FDA approved an efficacy supplement for Cabometyx (cabozantinib), Exelixis Inc, NDA208692 SUPPL-18. FDA letter.
Sep 10: the FDA approved an efficacy supplement for Koselugo (selumetinib), Astrazeneca, NDA213756 SUPPL-5. FDA letter.
Sep 15: the FDA approved an efficacy supplement for Airsupra (albuterol sulfate and budesonide), Astrazeneca, NDA214070 SUPPL-1. FDA letter.
Sep 16: the FDA approved an efficacy supplement for Ibrance (palbociclib), Pfizer, NDA212436 SUPPL-11. FDA letter.
Sep 16: the FDA approved an efficacy supplement for Ibrance (palbociclib), Pfizer, NDA207103 SUPPL-23. FDA letter.
Sep 18: the FDA approved an efficacy supplement for Opzelura (ruxolitinib), Incyte Corp, NDA215309 SUPPL-7. FDA letter.
Sep 19: the FDA approved an efficacy supplement for Tremfya (guselkumab), Janssen Biotech, BLA761061 SUPPL-26. FDA letter.
Sep 25: the FDA approved an efficacy supplement for Evkeeza (evinacumab-dgnb), Regeneron Pharmaceuticals, BLA761181 SUPPL-2. FDA letter.
Sep 26: the FDA approved an efficacy supplement for Tremfya (guselkumab), Janssen Biotech, BLA761061 SUPPL-29. FDA letter.
Sep 26: the FDA approved an efficacy supplement for Tremfya (guselkumab), Janssen Biotech, BLA761061 SUPPL-28. FDA letter.