🇺🇸 Sofosbuvir and Velpatasvir in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Sofosbuvir and Velpatasvir on 28 June 2016

Marketing authorisation

FDA — authorised 28 June 2016

Application: NDA208341
Marketing authorisation holder: GILEAD SCIENCES INC
Status: supplemented

Other Virology / Hepatology approved in United States

Frequently asked questions

Is Sofosbuvir and Velpatasvir approved in United States?

Yes. FDA authorised it on 28 June 2016.

Who is the marketing authorisation holder for Sofosbuvir and Velpatasvir in United States?

GILEAD SCIENCES INC holds the US marketing authorisation.