Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved 5 new drug or biologic applications and 12 efficacy supplements (new uses for approved drugs) in January 2026, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 5
Jan 12: the FDA approved Zycubo (copper histidinate), Sentynl Theraps Inc, NDA211241 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jan 15: the FDA approved Filkri (filgrastim-laha), Accord Biopharma Inc., BLA761027 ORIG-1. FDA letter.
Jan 21: the FDA approved Avtozma (tocilizumab), Celltrion Inc, BLA761498 ORIG-1. FDA letter.
Jan 26: the FDA approved Quiofic (folic acid), Solubiomix, NDA216395 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Jan 28: the FDA approved Yuvezzi (carbachol and brimonidine tartrate), Visus, NDA220142 ORIG-1 (Type 3 - New Dosage Form and Type 4 - New Combination). FDA letter.
New uses for approved drugs (efficacy supplements) · 12
Jan 12: the FDA approved an efficacy supplement for Cerezyme (imiglucerase), Genzyme, BLA020367 SUPPL-123. FDA letter.
Jan 16: the FDA approved an efficacy supplement for Nexplanon (etonogestrel), Organon, NDA021529 SUPPL-27. FDA letter.
Jan 21: the FDA approved an efficacy supplement for Verquvo (vericiguat), Msd, NDA214377 SUPPL-5. FDA letter.
Jan 23: the FDA approved an efficacy supplement for Afrezza (insulin human), Mannkind, BLA022472 SUPPL-27. FDA letter.
Jan 23: the FDA approved an efficacy supplement for Caldolor (ibuprofen), Apotex, NDA022348 SUPPL-28. FDA letter.
Jan 27: the FDA approved an efficacy supplement for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)), Janssen Biotech, BLA761145 SUPPL-28. FDA letter.
Jan 27: the FDA approved an efficacy supplement for Idose Tr (travoprost intracameral), Glaukos, NDA218010 SUPPL-4. FDA letter.
Jan 27: the FDA approved an efficacy supplement for Noxafil (posaconazole), Msd Merck Co, NDA214770 SUPPL-9. FDA letter.
Jan 27: the FDA approved an efficacy supplement for Noxafil (posaconazole), Merck Sharp Dohme, NDA205596 SUPPL-21. FDA letter.
Jan 27: the FDA approved an efficacy supplement for Noxafil (posaconazole), Schering, NDA022003 SUPPL-34. FDA letter.
Jan 27: the FDA approved an efficacy supplement for Noxafil (posaconazole), Merck Sharp Dohme, NDA205053 SUPPL-18. FDA letter.
Jan 27: the FDA approved an efficacy supplement for Vyxeos ((daunorubicin and cytarabine) liposome), Jazz Pharms Therap, NDA209401 SUPPL-18. FDA letter.