enforcement database
FDA NDA Approvals
14 documented actions on record. New Drug Application approvals -- novel (branded) drug approvals granted by the FDA.
- Total actions
- 14
- Earliest on record
- June 12, 2026
- Most recent
- July 16, 2026
- Source
- openFDA (approval)
Severity breakdown
- Informational14
Most recent nda approvals (14 of 14 shown)
- 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
- IONIS PHARMS INC — NDA approval: TRYNGOLZA (AUTOINJECTOR) (unspecified)
June 24, 2026·Informational
- AVYXA HOLDINGS — NDA approval: NAVITRUX (unspecified)
June 24, 2026·Informational
- ZEALAND PHARMA — NDA approval: ZEGALOGUE (unspecified)
June 18, 2026·Informational
- GLAXOSMITHKLINE — NDA approval: UTEBZI (unspecified)
June 17, 2026·Informational
- AZURITY — NDA approval: APREPITANT (unspecified)
June 16, 2026·Informational
- MERCK SHARP DOHME — NDA approval: WELIREG (unspecified)
June 12, 2026·Informational
- BAYER HEALTHCARE — NDA approval: AMBELVIST (unspecified)
June 12, 2026·Informational
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.