enforcement database
FDA NDA Approvals
33 documented actions on record. New Drug Application approvals -- novel (branded) drug approvals granted by the FDA.
- Total actions
- 33
- Earliest on record
- June 12, 2026
- Most recent
- August 28, 2026
- Source
- openFDA (approval)
Severity breakdown
- Informational33
Most recent nda approvals (30 of 33 shown)
- TAKEDA PHARMACEUTICALS U.S.A., INC. — NDA approval: MIMRYLO (unspecified)
August 28, 2026·Informational
- PRIOVANT THERAPEUTICS INC — NDA approval: Unspecified (unspecified)
August 27, 2026·Informational
- GILEAD SCIENCES INC — NDA approval: Unspecified (unspecified)
August 27, 2026·Informational
- GILEAD SCIENCES — NDA approval: BIXLENVO (unspecified)
August 27, 2026·Informational
- SUN PHARMACEUTICAL INDUSTRIES LIMITED — NDA approval: VOBRIG (unspecified)
August 26, 2026·Informational
- REVOLUTION MEDICINES INC — NDA approval: RASONQUE (unspecified)
August 26, 2026·Informational
- VIIV HLTHCARE — NDA approval: TIVICAY PD (unspecified)
August 25, 2026·Informational
- VIIV HLTHCARE — NDA approval: TIVICAY (unspecified)
August 25, 2026·Informational
- BAXTER HLTHCARE CORP — NDA approval: Unspecified (unspecified)
August 14, 2026·Informational
- BRISTOL MYERS SQUIBB — NDA approval: ZENBEXUS (unspecified)
August 13, 2026·Informational
- CERVEAU TECHNOLOGIES INC A LANTHEUS CO — NDA approval: TAUKLARIFY (unspecified)
August 13, 2026·Informational
- TAKEDA PHARMS USA — NDA approval: ORZEYFUL (unspecified)
August 5, 2026·Informational
- FRESENIUS KABI USA LLC — NDA approval: Unspecified (unspecified)
July 29, 2026·Informational
- CMP DEV LLC — NDA approval: QLONILIK (unspecified)
July 29, 2026·Informational
- VIATRIS SPECIALTY — NDA approval: GWYN LO (unspecified)
July 28, 2026·Informational
- KENVUE BRANDS LLC — NDA approval: TYLENOL WITH NAPROXEN (unspecified)
July 24, 2026·Informational
- OTSUKA PHARMACEUTICAL CO LTD — NDA approval: SIMTRIYO (unspecified)
July 24, 2026·Informational
- AETERNA ZENTARIS — NDA approval: MACRILEN (unspecified)
July 23, 2026·Informational
- NUVALENT INC — NDA approval: JIDEYTRO (unspecified)
July 22, 2026·Informational
- MERCK SHARP AND DOHME LLC — NDA approval: ENLICITIDE (unspecified)
July 16, 2026·Informational
- NOVARTIS — NDA approval: FABHALTA (unspecified)
July 16, 2026·Informational
- CELCUITY INC.. — NDA approval: REVTORPYK (unspecified)
July 14, 2026·Informational
- PROVEPHARM SAS — NDA approval: ZYOGREEN (unspecified)
July 10, 2026·Informational
- AMNEAL EU LTD — NDA approval: SODIUM BICARBONATE (unspecified)
July 9, 2026·Informational
- NOVARTIS — NDA approval: KISQALI (unspecified)
July 1, 2026·Informational
- NOVARTIS — NDA approval: KISQALI FEMARA CO-PACK (COPACKAGED) (unspecified)
July 1, 2026·Informational
- AVYXA HOLDINGS — NDA approval: NAVITRUX (unspecified)
June 24, 2026·Informational
- IONIS PHARMS INC — NDA approval: TRYNGOLZA (AUTOINJECTOR) (unspecified)
June 24, 2026·Informational
- ZEALAND PHARMA — NDA approval: ZEGALOGUE (unspecified)
June 18, 2026·Informational
- GLAXOSMITHKLINE — NDA approval: UTEBZI (unspecified)
June 17, 2026·Informational
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.