Perrigo Announces FDA Final Approval Of Betamethasone Valerate Foam 0.12%
Perrigo Company (Nasdaq: PRGO) today announced that its partner, Cobrek Pharmaceuticals, Inc., received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for betamethasone valerate foam 0.12%, the generic equivalent of Luxiq® Foam. Perrigo has manufactured the product and is preparing to commence commercial shipments on January 15, 2013, consistent with the date certain launch settlement. Cobrek was first to file, making the product eligible for 180 days of marketing exclusivity.
Betamethasone valerate foam 0.12% is indicated for the relief of corticosteroid-responsive skin conditions of the scalp (scalp psoriasis). Brand annual sales were approximately $40 million.
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