FDA — authorised 6 April 2011
- Application: NDA022405
- Marketing authorisation holder: GENZYME CORP
- Status: supplemented
🇺🇸 Caprelsa in United States
FDA authorised Caprelsa on 6 April 2011
Marketing authorisations
FDA
- Status: approved
Caprelsa 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 Caprelsa approved in United States?
Yes. FDA authorised it on 6 April 2011; FDA has authorised it.
Who is the marketing authorisation holder for Caprelsa in United States?
GENZYME CORP holds the US marketing authorisation.