Perrigo Company's partner Cobrek Pharmaceuticals, Inc., has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for betamethasone valerate foam 0.12 per cent, 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 per cent 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."
From its beginnings as a packager of generic home remedies in 1887, Perrigo Company, based in Allegan, Michigan, has grown to become a leading global provider of quality, affordable healthcare products. The Company develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, nutritional products and active pharmaceutical ingredients (API) and is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. Perrigo's mission is to offer uncompromised "quality, affordable healthcare products", and it does so across a wide variety of product categories primarily in the United States, United Kingdom, Mexico, Israel and Australia, as well as certain other markets throughout the world, including Canada, China and Latin America.