FDA — authorised 2 March 2021
- Marketing authorisation holder: COMMCAVE THERAPEUTICS SA
- Status: approved
🇺🇸 Azstarys in United States
FDA authorised Azstarys on 2 March 2021
Marketing authorisations
FDA — authorised 2 March 2021
- Application: NDA212994
- Marketing authorisation holder: COMMAVE THERAP
- Indication: Type 1 - New Molecular Entity and Type 4 - New Combination
- Status: approved
Azstarys in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Azstarys approved in United States?
Yes. FDA authorised it on 2 March 2021; FDA authorised it on 2 March 2021.
Who is the marketing authorisation holder for Azstarys in United States?
COMMCAVE THERAPEUTICS SA holds the US marketing authorisation.