🇺🇸 Ledipasvir and sofosbuvir in United States

FDA authorised Ledipasvir and sofosbuvir on 10 October 2014

Marketing authorisation

FDA — authorised 10 October 2014

  • Application: NDA205834
  • Marketing authorisation holder: GILEAD SCIENCES INC
  • Status: supplemented

Other Infectious Disease / Virology approved in United States

Frequently asked questions

Is Ledipasvir and sofosbuvir approved in United States?

Yes. FDA authorised it on 10 October 2014.

Who is the marketing authorisation holder for Ledipasvir and sofosbuvir in United States?

GILEAD SCIENCES INC holds the US marketing authorisation.