FDA — authorised 6 December 2013
- Application: NDA204671
- Marketing authorisation holder: GILEAD SCIENCES INC
- Local brand name: SOVALDI
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 SOF+DCV in United States
FDA authorised SOF+DCV on 6 December 2013
Marketing authorisations
FDA — authorised 24 July 2015
- Application: NDA206843
- Marketing authorisation holder: BRISTOL-MYERS SQUIBB
- Local brand name: DAKLINZA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 2019
- Application: NDA212480
- Marketing authorisation holder: GILEAD SCIENCES INC
- Local brand name: SOVALDI
- Indication: PELLETS — ORAL
- Status: approved
FDA
- Status: approved
SOF+DCV in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is SOF+DCV approved in United States?
Yes. FDA authorised it on 6 December 2013; FDA authorised it on 24 July 2015; FDA authorised it on 28 August 2019.
Who is the marketing authorisation holder for SOF+DCV in United States?
GILEAD SCIENCES INC holds the US marketing authorisation.