FDA grants final approval to Cobrek’s generic Luxiq foam NDA for treatment of scalp psoriasis
Published on November 28, 2012 at 1:40 AM
Perrigo Company (Nasdaq: PRGO;TASE) 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.
Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This is our sixth product approval using a foam dosage form, which requires specialized development and manufacturing capabilities. It is an example of the excellent partnership we have with Cobrek and we are committed to making quality healthcare more affordable for our customers and drive value for our shareholders."