FDA — authorised 26 August 2020
- Marketing authorisation holder: CASSIOPEA SPA
- Status: approved
🇺🇸 Winlevi in United States
FDA authorised Winlevi on 26 August 2020
Marketing authorisations
FDA — authorised 19 August 2021
- Application: NDA213433
- Marketing authorisation holder: SUN PHARM
- Indication: Supplement
- Status: approved
Winlevi in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Dermatology approved in United States
Frequently asked questions
Is Winlevi approved in United States?
Yes. FDA authorised it on 26 August 2020; FDA authorised it on 19 August 2021.
Who is the marketing authorisation holder for Winlevi in United States?
CASSIOPEA SPA holds the US marketing authorisation.