Perrigo Company announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for clindamycin phosphate and benzoyl peroxide 1.2% / 5% topical gel, the generic equivalent of Duac® Gel. Perrigo acquired the ANDA 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, Perrigo may be entitled to 180-days of marketing exclusivity and FDA has deferred determining Perrigo's exclusivity period until there is another ANDA in condition for approval. Patent litigation for this product was dismissed with prejudice in 2009. Perrigo has commenced shipment of the product.
Duac® Gel (clindamycin phosphate and benzoyl peroxide 1.2% / 5% gel) is indicated for the topical treatment of inflammatory acne vulgaris. Annual sales were approximately $130 million, as measured by Wolters Kluwer Health.
Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This approval is a testament to our continued commitment to bring new products first to market, our leadership in the topical space, and the diligent execution of our team. We're pleased to bring this new topical product to market and continue to focus on our mission of making healthcare more accessible and affordable for consumers."
Source: Perrigo Co.