FDA — authorised 10 August 2011
- Application: NDA202123
- Marketing authorisation holder: GILEAD SCIENCES INC
- Local brand name: COMPLERA
- Indication: TABLET — ORAL
- Status: approved
FDA authorised COMPLERA on 10 August 2011
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 10 August 2011; FDA has authorised it.
GILEAD SCIENCES INC holds the US marketing authorisation.