FDA — authorised 28 April 2022
- Marketing authorisation holder: MYOKARDIA INC
- Status: approved
🇺🇸 Camzyos in United States
FDA authorised Camzyos on 28 April 2022
Marketing authorisations
FDA — authorised 28 April 2022
- Application: NDA214998
- Marketing authorisation holder: BRISTOL
- Local brand name: CAMZYOS
- Indication: CAPSULE — ORAL
- Status: approved
The FDA approved Camzyos, a drug developed by Bristol, for its approved indication. The approval was granted on 17 April 2025, following a standard expedited pathway. The application number for this approval is NDA214998.
Camzyos in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Camzyos approved in United States?
Yes. FDA authorised it on 28 April 2022; FDA authorised it on 28 April 2022.
Who is the marketing authorisation holder for Camzyos in United States?
MYOKARDIA INC holds the US marketing authorisation.