FDA — authorised 1 January 2022
- Marketing authorisation holder: IDORSIA PHARMACEUTICALS LTD
- Status: approved
🇺🇸 Quviviq in United States
FDA authorised Quviviq on 1 January 2022
Marketing authorisations
FDA — authorised 8 November 2022
- Application: NDA214985
- Marketing authorisation holder: IDORSIA
- Indication: Labeling
- Status: approved
Quviviq in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Quviviq approved in United States?
Yes. FDA authorised it on 1 January 2022; FDA authorised it on 8 November 2022.
Who is the marketing authorisation holder for Quviviq in United States?
IDORSIA PHARMACEUTICALS LTD holds the US marketing authorisation.