(By Balaseshan) Perrigo Co. (NASDAQ: PRGO) said its partner received U.S. Food and Drug Administration final approval of betamethasone valerate foam 0.12%, the generic equivalent of Luxiq Foam.
Cobrek Pharmaceuticals Inc. received final approval for its Abbreviated New Drug Application (ANDA) for betamethasone valerate foam 0.12%, which is indicated for the relief of corticosteroid-responsive skin conditions of the scalp (scalp psoriasis).
Perrigo has manufactured the product and is preparing to begin 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.
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"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," said Joseph Papa, CEO of Perrigo.
Perrigo is a global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and generic prescription pharmaceuticals, infant formulas, nutritional products and active pharmaceutical ingredients (API).
The company is the store brand manufacturer of OTC pharmaceutical products and infant formulas. The company has four segments, aligned primarily by type of product: consumer healthcare, nutritionals, prescription pharmaceuticals and API.
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PRGO is trading down 0.30 percent at $102.27 on Tuesday. The stock has been trading between $90.18 and $120.78 for the past 52 weeks.