Sun Pharmaceutical Industries Ltd on Tuesday said the Australian Therapeutic Goods Administration has granted regulatory approval for Winlevi cream indicated for the topical treatment of acne.
The approval is for Winlevi (clascoterone cream 1%), which is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older, the company said in a statement.
Sun Pharma received the exclusive right to develop and commercialise Winlevi in the US, Japan, Australia, New Zealand, Brazil, Mexico, and Russia from Cosmo, it added.
"Winlevi is an exciting addition to our expanding dermatology portfolio of innovative medicines in Australia. Winlevi's novel mechanism of action will be a welcome addition to the physician's toolkit while treating acne," Hellen de Kloet, Business Head, Western Europe, Australia and New Zealand, Sun Pharma, said.
The company said Winlevi will be available in Australia this June.
"This is another achievement in the mission of Cosmo and Sun Pharma to improve the lives of patients affected by skin conditions," Cosmo President of the Dermatology Division Diana Harbort said.
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