enforcement database
FDA NDA Approvals
52 documented actions on record. New Drug Application approvals -- novel (branded) drug approvals granted by the FDA.
- Total actions
- 52
- Earliest on record
- June 12, 2026
- Most recent
- October 8, 2026
- Source
- openFDA (approval)
Severity breakdown
- Informational52
Most recent nda approvals (30 of 52 shown)
- TEVA NEUROSCIENCE INC — NDA approval: WELTRUZA (unspecified)
October 8, 2026·Informational
- ASTRAZENECA AB — NDA approval: BREZTRI AEROSPHERE (unspecified)
October 8, 2026·Informational
- EVER VALINJECT — NDA approval: Unspecified (unspecified)
October 1, 2026·Informational
- BRISTOL — NDA approval: CAMZYOS (unspecified)
September 30, 2026·Informational
- RARE THYROID THERAPEUTICS INTERNATIONAL AB — NDA approval: EMCITATE (unspecified)
September 28, 2026·Informational
- ABBVIE INC — NDA approval: JUVMO (unspecified)
September 25, 2026·Informational
- INCYTE CORP — NDA approval: ATEBRIOZ (unspecified)
September 25, 2026·Informational
- AZURITY PHARMACEUTICALS INC — NDA approval: Unspecified (unspecified)
September 25, 2026·Informational
- ADVENTAPHARMA DWC LLC — NDA approval: ZUEINO (unspecified)
September 25, 2026·Informational
- ELEVAR THERAPEUTICS INC — NDA approval: LYRFIGTU (unspecified)
September 23, 2026·Informational
- INTRABIO — NDA approval: AQNEURSA (unspecified)
September 18, 2026·Informational
- BAYER HLTHCARE — NDA approval: KERENDIA (unspecified)
September 16, 2026·Informational
- CURIUM — NDA approval: BEXLUTRY (unspecified)
September 14, 2026·Informational
- TELIX PHARMACEUTICALS US INC — NDA approval: PIXCLARA (unspecified)
September 11, 2026·Informational
- PHARMING — NDA approval: JOENJA (unspecified)
September 11, 2026·Informational
- BAYER HEALTHCARE — NDA approval: HYRNUO (unspecified)
September 9, 2026·Informational
- ASTRAZENECA PHARMACEUTICALS, LP — NDA approval: ETCAMAH (unspecified)
September 4, 2026·Informational
- IONIS PHARMS INC — NDA approval: ZANVASTRO (unspecified)
September 3, 2026·Informational
- HANDA ONCOLOGY, LLC — NDA approval: Unspecified (unspecified)
September 3, 2026·Informational
- TAKEDA PHARMACEUTICALS U.S.A., INC. — NDA approval: MIMRYLO (unspecified)
August 28, 2026·Informational
- GILEAD SCIENCES — NDA approval: BIXLENVO (unspecified)
August 27, 2026·Informational
- GILEAD SCIENCES INC — NDA approval: Unspecified (unspecified)
August 27, 2026·Informational
- PRIOVANT THERAPEUTICS INC — NDA approval: Unspecified (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 (unspecified)
August 25, 2026·Informational
- VIIV HLTHCARE — NDA approval: TIVICAY PD (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
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.