FDA — authorised 6 April 2011
- Marketing authorisation holder: IPR PHARMS INC
- Status: approved
🇺🇸 Caprelsa in United States
FDA authorised Caprelsa on 6 April 2011
Marketing authorisations
FDA — authorised 23 September 2025
- Application: NDA022405
- Marketing authorisation holder: GENZYME CORP
- Indication: REMS
- Status: approved
The FDA approved Caprelsa, manufactured by Genzyme Corp, for a Risk Evaluation and Mitigation Strategy (REMS) indication. This approval was granted through a standard expedited pathway. The application number for this approval is NDA022405.
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 authorised it on 23 September 2025.
Who is the marketing authorisation holder for Caprelsa in United States?
IPR PHARMS INC holds the US marketing authorisation.