Acetadote (acetylcysteine) PDUFA Date (Apotex)
FDA PDUFA decision date for Acetadote (acetylcysteine) is July 23, 2025. Developed by Apotex. Indication: Antidote [EPC], Antidote for Acetaminophen Overdose [EPC]. Current status: Approved.
Indication
Antidote [EPC], Antidote for Acetaminophen Overdose [EPC]
Regulatory details
- Company: Apotex
- Application type: sNDA
- Review type: Standard
- PDUFA date: 2025-07-23
- Outcome: Approved