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Perrigo receives US FDA approval for Ketoconazole Foam, 2%
Allegan, Michigan | Wednesday, August 31, 2011, 16:00 Hrs  [IST]

Perrigo Company announced that it has received final approval from the US 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.”

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients (API) and pharmaceutical and medical diagnostic products.

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