FDA — authorised 11 August 2022
- Application: NDA022395
- Marketing authorisation holder: AVERITAS
- Indication: Labeling
- Status: approved
🇺🇸 Qutenza in United States
FDA authorised Qutenza on 11 August 2022
Marketing authorisation
Qutenza 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 Qutenza approved in United States?
Yes. FDA authorised it on 11 August 2022.
Who is the marketing authorisation holder for Qutenza in United States?
AVERITAS holds the US marketing authorisation.