Perrigo Company (Nasdaq: PRGO; TASE) 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.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "This launch reflects our continuing investment in new products. It is an example of the excellent partnership we have with Cobrek for developing foam products which is a key product category for our Rx business. Perrigo is committed to making quality healthcare more affordable for our customers and drive value for our shareholders."
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