US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
| WINLEVI | 1% | cream · topical | SUN PHARM | Prescription | 26 Aug 2020 |
EMA European Union — centrally authorised medicines
Winlevi Cassiopea S.p.A. · Authorised · authorised 17 Oct 2025 · ATC D10AX06
Therapeutic indication (EMA)
Adults Winlevi is indicated for the treatment of acne vulgaris. Adolescents (from 12 to < 18 years of age) Winlevi is indicated for the treatment of facial acne vulgaris.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
| WINLEVI | 02538881 | 1 % / W/W | CREAM · TOPICAL | SUN PHARMACEUTICAL INDUSTRIES LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
| US NADAC | WINLEVI 1% CREAM | $10.00099 | per GM | 23 Sep 2026 |
| NHS Drug Tariff | Clascoterone 10mg/g cream | £19.43 | 60 gram | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.