Medrol (methylprednisolone) PDUFA Date (Pfizer)

Name: FDA PDUFA Decision: Medrol (methylprednisolone)
Start: 2025-11-04

FDA PDUFA decision date for Medrol (methylprednisolone) is November 4, 2025. Developed by Pfizer. Indication: Corticosteroid [EPC]. Current status: Approved.

Indication

Corticosteroid [EPC]

Regulatory details

Company: Pfizer
Application type: sNDA
Review type: Standard
PDUFA date: 2025-11-04
Outcome: Approved

Medrol (methylprednisolone) PDUFA Date — Pfizer