Perrigo Announces FDA Final Approval for Ketoconazole Foam, 2%
ALLEGAN -- Perrigo Co. (Nasdaq: PRGO) Tuesday announced that it has received final approval from the United States 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. This product is indicated for topical treatment of seborrheic dermatitis in patients 12 years of age and older with healthy immune systems.
"This launch reflects our continuing investment in new products," said Perrigo chairman and CEO Joseph C. Papa. "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."
Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients and pharmaceutical and medical diagnostic products. The company is the world's largest store brand manufacturer of OTC pharmaceutical products and infant formulas. The company's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.
More at www.perrigo.com.