FDA — authorised 12 August 2013
- Marketing authorisation holder: VIIV HLTHCARE
- Status: approved
🇺🇸 Tivicay in United States
FDA authorised Tivicay on 12 August 2013
Marketing authorisations
FDA — authorised 1 April 2016
- Application: NDA205551
- Marketing authorisation holder: VIIV HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 6 August 2020
- Application: NDA211994
- Marketing authorisation holder: VIIV HLTHCARE
- Indication: Efficacy
- Status: approved
FDA — authorised 23 March 2021
- Application: NDA210192
- Marketing authorisation holder: VIIV HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 23 March 2021
- Application: NDA213983
- Marketing authorisation holder: VIIV HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 7 October 2022
- Application: NDA215413
- Marketing authorisation holder: VIIV HLTHCARE
- Indication: Labeling
- Status: approved
Tivicay 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 Tivicay approved in United States?
Yes. FDA authorised it on 12 August 2013; FDA authorised it on 1 April 2016; FDA authorised it on 6 August 2020.
Who is the marketing authorisation holder for Tivicay in United States?
VIIV HLTHCARE holds the US marketing authorisation.