FDA approves Perrigo acne treatment

Drug maker first to win approval for generic version of Stiefel's Duac

ALLEGAN, Mich. — The Food and Drug Administration has approved an acne treatment made by Perrigo, the drug maker said Wednesday.

Perrigo announced the approval of clindamycin phosphate and benzoyl peroxide topical gel in the 1.2%/5% strength. The drug is a generic version of Duac, made by GlaxoSmithKline subsidiary Stiefel. Perrigo's 2009 regulatory application for the drug included a paragraph IV certification, a legal assertion that the branded drug's patent protection is invalid, unenforceable or won't be infringed; the approval entitles Perrigo's generic to 180 days of market exclusivity in which to directly compete with the branded version.

Duac has annual sales of about $130 million, according to Wolters Kluwer Health.


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