Perrigo gets tentative FDA nod for Acanya generic
SILVER SPRING, Md. — Perrigo has received tentative approval from the Food and Drug Administration for its generic of Acanya (clindamycin phosphate, 1.2%, and benzoyl peroxide, 2.5%), the company announced Monday. Perrigo has previously settled litigation with Valeant Pharmaceuticals North America and Dow Pharmaceuticals concerning the product.
The drug is indicated to treat acne vulgaris in patients ages 12 years and older. It had U.S. sales of roughly $57 million for the 12 months ended July 2017, Perrigo said.
"The [research and development] team continues its efforts to achieve regulatory approvals for important new products,” Perrigo EVP and president Rx pharmaceuticals John Wesolowski said. This tentative approval reflects our continued dedication to developing extended topical products for patients."