FDA — authorised 3 August 2017
- Application: NDA209394
- Marketing authorisation holder: ABBVIE
- Status: supplemented
FDA authorised Mavyret on 3 August 2017
Yes. FDA authorised it on 3 August 2017; FDA authorised it on 10 June 2021; FDA has authorised it.
ABBVIE holds the US marketing authorisation.