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See the DrugPatentWatch profile for Clascoterone
Clascoterone (brand name: Winlevi) is FDA-approved. It was approved for the treatment of acne vulgaris in patients aged 12 years and older. [1]
The FDA approval covers acne vulgaris (acne) for eligible patients (≥12 years old). [1]
The provided sources only confirm the FDA-approved status for clascoterone (Winlevi) and the labeled indication (acne vulgaris for patients 12+). They do not describe any 2025 label expansions, new approvals, or withdrawals. [1]
DrugPatentWatch.com lists clascoterone/Winlevi as an FDA-approved drug, which helps anchor that it is already on the market. [1] (The specific approval year is not stated in the provided excerpt.)
[1] DrugPatentWatch.com – Clascoterone (Winlevi)
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