FDA — authorised 28 January 2016
- Marketing authorisation holder: MERCK SHARP DOHME
- Status: approved
🇺🇸 Zepatier in United States
FDA authorised Zepatier on 28 January 2016
Marketing authorisations
FDA — authorised 28 January 2016
- Application: NDA208261
- Marketing authorisation holder: MSD SUB MERCK
- Local brand name: ZEPATIER
- Indication: TABLET — ORAL
- Status: approved
Zepatier in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Zepatier approved in United States?
Yes. FDA authorised it on 28 January 2016; FDA authorised it on 28 January 2016.
Who is the marketing authorisation holder for Zepatier in United States?
MERCK SHARP DOHME holds the US marketing authorisation.