FDA — authorised 27 August 2012
- Marketing authorisation holder: GILEAD SCIENCES INC
- Status: approved
🇺🇸 Vitekta in United States
FDA authorised Vitekta on 27 August 2012
Marketing authorisations
FDA — authorised 28 August 2014
- Application: NDA203100
- Marketing authorisation holder: GILEAD SCIENCES INC
- Indication: Efficacy
- Status: approved
FDA — authorised 18 March 2019
- Application: NDA207561
- Marketing authorisation holder: GILEAD SCIENCES INC
- Indication: Labeling
- Status: approved
Vitekta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Vitekta approved in United States?
Yes. FDA authorised it on 27 August 2012; FDA authorised it on 28 August 2014; FDA authorised it on 18 March 2019.
Who is the marketing authorisation holder for Vitekta in United States?
GILEAD SCIENCES INC holds the US marketing authorisation.