🇺🇸 Mavyret in United States

FDA authorised Mavyret on 3 August 2017

Marketing authorisations

FDA — authorised 3 August 2017

  • Application: NDA209394
  • Marketing authorisation holder: ABBVIE
  • Status: supplemented

FDA — authorised 10 June 2021

  • Application: NDA215110
  • Marketing authorisation holder: ABBVIE
  • Status: approved

FDA

  • Status: approved

Other Other approved in United States

Frequently asked questions

Is Mavyret approved in United States?

Yes. FDA authorised it on 3 August 2017; FDA authorised it on 10 June 2021; FDA has authorised it.

Who is the marketing authorisation holder for Mavyret in United States?

ABBVIE holds the US marketing authorisation.