FDA — authorised 22 October 2020
- Marketing authorisation holder: GILEAD SCIENCES INC
- Status: approved
FDA authorised Veklury on 22 October 2020
GILEAD SCIENCES INC received marketing authorisation for Veklury from the FDA on 2024-12-19. The application number for this approval is NDA214787. The marketing authorisation holder is GILEAD SCIENCES INC, and the drug's indication is listed in the labelling.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 22 October 2020; FDA authorised it on 19 December 2024.
GILEAD SCIENCES INC holds the US marketing authorisation.