How many drugs did the FDA approve in October 2025?

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FDA approvals, October 2025

Page updated November 12, 2026·next FDA decision on the calendar ·Data as of Nov 12, 2026 2:24 AM ET

The FDA approved 20 new drug or biologic applications and 30 efficacy supplements (new uses for approved drugs) in October 2025, per Drugs@FDA as read on 2026-11-12.

New drug and biologic applications · 20

Oct 2: the FDA approved Eydenzelt (aflibercept-boav), Celltrion Inc, BLA761377 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Oct 7: the FDA approved Jascayd (nerandomilast), Boehringer Ingelheim, NDA218764 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Oct 7: the FDA approved Lasix Onyu (furosemide), Sq Innovation, NDA217294 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Oct 15: the FDA approved , Merck Sharp And Dohme Llc, BLA761495 ORIG-1 (Type 9 - New indication submitted as distinct BLA, consolidated). FDA letter.
Oct 16: the FDA approved Ferabright (ferumoxytol), Azurity, NDA219868 ORIG-1 (Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated). FDA letter.
Oct 17: the FDA approved Epioxa Cross-Linking (riboflavin 5-phosphate ophthalmic), Glaukos, NDA219910 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Oct 22: the FDA approved Contepo (fosfomycin disodium), Meitheal, NDA212271 ORIG-1 (Type 2 - New Active Ingredient). FDA letter.
Oct 23: the FDA approved Blenrep (belantamab mafodotin), Glaxosmithkline Llc, BLA761440 ORIG-1 (Type 2 - New Active Ingredient). FDA letter.
Oct 23: the FDA approved Dehydrated Alcohol, Be Pharms, NDA214988 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Oct 23: the FDA approved Javadin (clonidine hydrochloride oral), Azurity, NDA220256 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Oct 24: the FDA approved Lynkuet (elinzanetant), Bayer Hlthcare, NDA219469 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Oct 24: the FDA approved Rocuronium Bromide, B Braun Medical, NDA219108 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Oct 25: the FDA approved Carbon Dioxide, Usp (carbon dioxide), Roberts Oxygen Co Inc, NDA221021 ORIG-1. FDA letter.
Oct 29: the FDA approved Bilprevda (denosumab), Shanghai Henlius Biotech, BLA761444 ORIG-2 (Efficacy). FDA letter.
Oct 29: the FDA approved Bosaya (denosumab-kyqq), Biocon Biologics Inc, BLA761436 ORIG-2 (Efficacy). FDA letter.
Oct 29: the FDA approved Conexxence (denosumab), Fresenius Kabi Usa Llc, BLA761398 ORIG-2 (Efficacy). FDA letter.
Oct 29: the FDA approved Enoby (denosumab-qbde), Hikma Pharmaceuticals Usa Inc, BLA761439 ORIG-2 (Efficacy). FDA letter.
Oct 29: the FDA approved Jubereq (denosumab-desu), Accord Biopharma Inc., BLA761424 ORIG-1. FDA letter.
Oct 29: the FDA approved Ospomyv (denosumab), Samsung Bioepis Co Ltd, BLA761392 ORIG-2 (Efficacy). FDA letter.
Oct 29: the FDA approved Stoboclo (denosumab-bmwo), Celltrion Inc, BLA761404 ORIG-2 (Efficacy). FDA letter.

New uses for approved drugs (efficacy supplements) · 30

Oct 2: the FDA approved an efficacy supplement for Scemblix (asciminib), Novartis, NDA215358 SUPPL-10. FDA letter.
Oct 2: the FDA approved an efficacy supplement for Tecentriq (atezolizumab), Genentech Inc, BLA761034 SUPPL-58.
Oct 2: the FDA approved an efficacy supplement for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), Genentech Inc, BLA761347 SUPPL-3.
Oct 2: the FDA approved an efficacy supplement for Zepzelca (lurbinectedin), Jazz, NDA213702 SUPPL-11. FDA letter.
Oct 3: the FDA approved an efficacy supplement for Axtle (pemetrexed), Avyxa Holdings, NDA210661 SUPPL-4. FDA letter.
Oct 4: the FDA approved an efficacy supplement for Zoryve (roflumilast), Arcutis, NDA215985 SUPPL-12. FDA letter.
Oct 7: the FDA approved an efficacy supplement for Simponi (golimumab), Centocor Ortho Biotech Inc, BLA125289 SUPPL-157. FDA letter.
Oct 8: the FDA approved an efficacy supplement for Libtayo (cemiplimab-rwlc), Regeneron Pharmaceuticals, BLA761097 SUPPL-30. FDA letter.
Oct 9: the FDA approved an efficacy supplement for Praluent (alirocumab), Regeneron Pharmaceuticals, BLA125559 SUPPL-47. FDA letter.
Oct 10: the FDA approved an efficacy supplement for Iclusig (ponatinib hydrochloride), Takeda Pharms Usa, NDA203469 SUPPL-38. FDA letter.
Oct 10: the FDA approved an efficacy supplement for Isovue 200 (iopamidol), Bracco, NDA018735 SUPPL-75. FDA letter.
Oct 10: the FDA approved an efficacy supplement for Olpruva (sodium phenylbutyrate), Acer, NDA214860 SUPPL-7. FDA letter.
Oct 10: the FDA approved an efficacy supplement for Rinvoq (upadacitinib), Abbvie, NDA211675 SUPPL-28. FDA letter.
Oct 10: the FDA approved an efficacy supplement for Uzedy (risperidone), Teva, NDA213586 SUPPL-8. FDA letter.
Oct 16: the FDA approved an efficacy supplement for Xeljanz (tofacitinib), Pfizer, NDA213082 SUPPL-11. FDA letter.
Oct 16: the FDA approved an efficacy supplement for Xeljanz (tofacitinib), Pf Prism Cv, NDA203214 SUPPL-39. FDA letter.
Oct 16: the FDA approved an efficacy supplement for Ztalmy (ganaxolone), Immedica Pharma, NDA215904 SUPPL-11. FDA letter.
Oct 17: the FDA approved an efficacy supplement for Gazyva (obinutuzumab), Genentech, BLA125486 SUPPL-38. FDA letter.
Oct 17: the FDA approved an efficacy supplement for Gazyva (obinutuzumab), Genentech, BLA125486 SUPPL-37. FDA letter.
Oct 17: the FDA approved an efficacy supplement for Ozempic (oral semaglutide), Novo, NDA213051 SUPPL-24. FDA letter.
Oct 17: the FDA approved an efficacy supplement for Tezspire (tezepelumab-ekko), Astrazeneca Ab, BLA761224 SUPPL-6. FDA letter.
Oct 17: the FDA approved an efficacy supplement for Vyvgart (efgartigimod alfa), Argenx Bv, BLA761195 SUPPL-12. FDA letter.
Oct 17: the FDA approved an efficacy supplement for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)), Argenx Bv, BLA761304 SUPPL-10. FDA letter.
Oct 20: the FDA approved an efficacy supplement for Beyfortus (nirsevimab), Astrazeneca Ab, BLA761328 SUPPL-12. FDA letter.
Oct 22: the FDA approved an efficacy supplement for Vyepti (eptinezumab-jjmr), Lundbeck Seattle Biopharmaceuticals, Inc., BLA761119 SUPPL-11. FDA letter.
Oct 24: the FDA approved an efficacy supplement for Revuforj (revumenib), Syndax, NDA218944 SUPPL-3. FDA letter.
Oct 24: the FDA approved an efficacy supplement for Winrevair (sotatercept-csrk), Merck Sharp Dohme, BLA761363 SUPPL-7. FDA letter.
Oct 27: the FDA approved an efficacy supplement for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy), Bristol-Myers Squibb, BLA761381 SUPPL-2. FDA letter.
Oct 27: the FDA approved an efficacy supplement for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy), Bristol-Myers Squibb, BLA761381 SUPPL-1. FDA letter.
Oct 29: the FDA approved an efficacy supplement for Libtayo (cemiplimab-rwlc), Regeneron Pharmaceuticals, BLA761097 SUPPL-32. 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. ← September 2025 · November 2025 → · all months · PDUFA decisions this month · decisions we tracked in 2025