FDA — authorised 14 March 2011
- Application: NDA201277
- Marketing authorisation holder: BAYER HLTHCARE
- Status: approved
🇺🇸 Gadavist in United States
FDA authorised Gadavist on 14 March 2011
Marketing authorisations
FDA
- Status: approved
Gadavist in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Gadavist approved in United States?
Yes. FDA authorised it on 14 March 2011; FDA has authorised it.
Who is the marketing authorisation holder for Gadavist in United States?
BAYER HLTHCARE holds the US marketing authorisation.