Mylan has acquired the abbreviated new drug application (ANDA) of the generic version of Valeant’s BenzaClin, Clindamycin Phosphate / Benzoyl Peroxide Gel.
Mylan also has purchased a license to manufacture and market Fluorouracil 5% USP cream as the exclusive authorized generic to Valeant’s Efudex.
Clindamycin Phosphate / Benzoyl Peroxide Gel, 1%/5%, is indicated for the topical treatment of acne vulgaris.
Fluorouracil 5% USP cream, is recommended for the topical treatment of multiple actinic or solar keratoses and for the treatment of superficial basal cell carcinomas when conventional methods are impractical.
Mylan CEO Heather Bresch said the acquisition will allow them to expand their portfolio of difficult-to-manufacture or limited-competition products.