New Launch18 Nov 2025, 02:45 pm
Glenmark and Cosmo Announce Market Authorization of Winlevi® for Acne Treatment in 15 European Countries
AI Summary
Cosmo Pharmaceuticals N.V. and Glenmark Pharmaceuticals Limited have announced that the European Commission has granted Marketing Authorization for Winlevi® (clascoterone 10 mg/g cream) for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years. The usage in adolescents is limited to facial application. Glenmark will initiate commercializing Winlevi® across 15 countries in the European Union. This approval is a key milestone for Glenmark in executing its mission to become a research-led, global pharmaceutical company and strengthening its presence in Dermatology in the region.
Key Highlights
- Winlevi® is authorized in EU for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years
- Glenmark will initiate commercializing Winlevi® across 15 countries in EU
- This approval is a key milestone for Glenmark in executing its mission to become a research-led, global pharmaceutical company
- Winlevi® is the first NCE launch of Glenmark in Europe and is key to strengthening its presence in Dermatology in the region
- The European Commission has granted Marketing Authorization for Winlevi® (clascoterone 10 mg/g cream)