FDA — authorised 3 August 2017
- Marketing authorisation holder: ABBVIE INC
- Status: approved
🇺🇸 Mavyret in United States
FDA authorised Mavyret on 3 August 2017
Marketing authorisations
FDA — authorised 3 August 2017
- Application: NDA209394
- Marketing authorisation holder: ABBVIE
- Local brand name: MAVYRET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 June 2021
- Application: NDA215110
- Marketing authorisation holder: ABBVIE
- Local brand name: MAVYRET
- Indication: PELLETS — ORAL
- Status: approved
Mavyret in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology 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 3 August 2017; FDA authorised it on 10 June 2021.
Who is the marketing authorisation holder for Mavyret in United States?
ABBVIE INC holds the US marketing authorisation.