ALLEGAN, Mich. — Perrigo Co. has received approval from the Food and Drug Administration for clindamycin phosphate and benzoyl peroxide 1.2%/5% topical gel, a treatment for acne.
The company said Wednesday that it has begun shipment of the product, the generic equivalent of Stiefel’s Duac Gel.
According to Wolters Kluwer Health data, annual sales total $130 million for Duac Gel, which is indicated for the topical treatment of inflammatory acne vulgaris.
Perrigo said it acquired the abbreviated new drug application (ANDA) for its clindamycin phosphate/benzoyl peroxide product in 2009, transferred production to a Perrigo manufacturing facility, and submitted an amendment to the ANDA, which was the first submission with a paragraph IV certification
The company added that it may be entitled to 180 days of marketing exclusivity and that the FDA has deferred determining Perrigo’s exclusivity period until there is another ANDA in condition for approval. Patent litigation for the product was dismissed in 2009, according to Perrigo.
