FDA — authorised 27 May 2016
- Marketing authorisation holder: BLUE EARTH DIAGNOSTICS LTD
- Status: approved
🇺🇸 Axumin in United States
FDA authorised Axumin on 27 May 2016
Marketing authorisation
Axumin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Axumin approved in United States?
Yes. FDA authorised it on 27 May 2016.
Who is the marketing authorisation holder for Axumin in United States?
BLUE EARTH DIAGNOSTICS LTD holds the US marketing authorisation.