ALLEGAN, Mich. — Drug maker Perrigo has filed with the Food and Drug Administration for approval of a generic topical ointment for treating acne in adolescents and adults, the company said Wednesday.
Perrigo said it filed for approval of clindamycin phosphate and benzoyl peroxide gel in the 1.2%/2.5% strengths. The drug is used to treat acne in patients 12 years and older.
The drug is a generic version of Dow Pharmasciences' Acanya gel, which has annual sales of about $122 million, according to Symphony Health Solutions. Perrigo said it notified Dow of the filing, to which Dow responded by filing suit against Perrigo in the U.S. District Court for the District of New Jersey, alleging patent infringement. Under the Hatch-Waxman Act of 1984, the suit puts an automatic stay of FDA approval on Perrigo's product for 30 months, or until the companies settle the case.