Perrigo Company has received final FDA approval for its abbreviated new drug application (ANDA) for clindamycin phosphate and benzoyl peroxide 1.2% / 5% topical gel, the generic equivalent of Duac gel.
Duac Gel is indicated for the topical treatment of inflammatory acne vulgaris.
Perrigo chairman, president and CEO Joseph Papa said, "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."
In 2009, Perrigo acquired the ANDA, transferred production to a manufacturing facility, and submitted an amendment to the ANDA.
The amendment 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 the product was dismissed with prejudice in 2009 and the company has begun shipment of the product.
