FDA — authorised 4 April 2016
- Application: NDA208215
- Marketing authorisation holder: GILEAD SCIENCES INC
- Local brand name: DESCOVY
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Descovy in United States
FDA authorised Descovy on 4 April 2016
Marketing authorisations
FDA
- Status: approved
Descovy 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 Descovy approved in United States?
Yes. FDA authorised it on 4 April 2016; FDA has authorised it.
Who is the marketing authorisation holder for Descovy in United States?
GILEAD SCIENCES INC holds the US marketing authorisation.