Perrigo Announces FDA Final Approval for Ketoconazole Foam. 2%

Perrigo Company PRGO today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Ketoconazole Foam, 2%, the generic version of Extina® Ketoconazole Foam, 2%. Perrigo has commenced shipping of the product and was first to file, enabling 180 days of marketing exclusivity. This product is part of the Perrigo/Cobrek collaboration. Extina® Ketoconazole Foam, 2% has annual retail sales of approximately $10 million dollars. This product is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.