Ogivri (trastuzumab-dkst) PDUFA Date (Mylan Gmbh)
FDA PDUFA decision date for Ogivri (trastuzumab-dkst) is November 13, 2024. Developed by Mylan Gmbh. Indication: HER2/neu Receptor Antagonist [EPC]. Current status: Approved.
Indication
HER2/neu Receptor Antagonist [EPC]
Regulatory details
- Company: Mylan Gmbh
- Application type: sBLA
- Review type: Standard
- PDUFA date: 2024-11-13
- Outcome: Approved