FDA — authorised 2 July 2020
- Marketing authorisation holder: ViiV Healthcare Company
- Status: approved
🇺🇸 Rukobia in United States
FDA authorised Rukobia on 2 July 2020
Marketing authorisations
FDA — authorised 24 January 2022
- Application: NDA212950
- Marketing authorisation holder: VIIV HLTHCARE
- Indication: Efficacy
- Status: approved
Rukobia 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 Rukobia approved in United States?
Yes. FDA authorised it on 2 July 2020; FDA authorised it on 24 January 2022.
Who is the marketing authorisation holder for Rukobia in United States?
ViiV Healthcare Company holds the US marketing authorisation.