FDA — authorised 20 January 2023
- Application: NDA214373
- Marketing authorisation holder: THERACOSBIO
- Local brand name: BRENZAVVY
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Brenzavvy in United States
FDA authorised Brenzavvy on 20 January 2023
Marketing authorisation
Brenzavvy 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 Brenzavvy approved in United States?
Yes. FDA authorised it on 20 January 2023.
Who is the marketing authorisation holder for Brenzavvy in United States?
THERACOSBIO holds the US marketing authorisation.