Gadavist (gadobutrol) PDUFA Date (Bayer Hlthcare)

Name: FDA PDUFA Decision: Gadavist (gadobutrol)
Start: 2026-07-28

FDA PDUFA decision date for Gadavist (gadobutrol) is July 28, 2026. Developed by Bayer Hlthcare. Indication: Gadolinium-based Contrast Agent [EPC]. Current status: Approved.

Indication

Gadolinium-based Contrast Agent [EPC]

Regulatory details

Company: Bayer Hlthcare
Application type: sNDA
Review type: Standard
PDUFA date: 2026-07-28
Outcome: Approved

Gadavist (gadobutrol) PDUFA Date — Bayer Hlthcare