FDA — authorised 14 March 2011
- Marketing authorisation holder: BAYER HLTHCARE
- Status: approved
🇺🇸 Gadavist in United States
FDA authorised Gadavist on 14 March 2011
Marketing authorisations
FDA — authorised 14 March 2011
- Application: NDA201277
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: GADAVIST
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 15 March 2023
- Application: ANDA217480
- Marketing authorisation holder: HAINAN POLY PHARM
- Local brand name: GADOBUTROL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 8 September 2023
- Application: ANDA216081
- Marketing authorisation holder: HENGRUI PHARMA
- Local brand name: GADOBUTROL
- Indication: SOLUTION — INTRAVENOUS
- 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 Hematology approved in United States
Frequently asked questions
Is Gadavist approved in United States?
Yes. FDA authorised it on 14 March 2011; FDA authorised it on 14 March 2011; FDA authorised it on 15 March 2023.
Who is the marketing authorisation holder for Gadavist in United States?
BAYER HLTHCARE holds the US marketing authorisation.