Perrigo Announces FDA Final Approval Of Tris Pharma's Dextromethorphan Polistirex Extended-Release Oral Suspension
ALLEGAN, Mich., May 30, 2012 /PRNewswire/ -- Perrigo Company (PRGO) today announced that the U.S. Food and Drug Administration has granted final approval to Tris Pharma for its abbreviated new drug application (ANDA) for Dextromethorphan Polistirex Extended-Release Oral Suspension, the store brand equivalent to Reckitt Benckiser's Delsym® suspension. As the exclusive marketer and distributor of this product for the store brand over-the-counter (OTC) market in the United States, Perrigo expects to begin shipping its product during its first fiscal quarter of 2013.
Litigation between Tris and Reckitt Benckiser is ongoing in the United States District Court for the District of New Jersey, where the court has previously granted summary judgment of non-infringement of the asserted patent claims. As the Tris ANDA was the first one submitted with a paragraph IV certification, marketing of the product is entitled to 180 days of generic exclusivity.
Delsym® is indicated for the treatment of cough due to minor throat and bronchial irritation. Perrigo estimates the past 52-weeks sales for the brand were approximately $110 million.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This approval further highlights our ability to bring new products to our consumers and reinforces our continued focus of making quality healthcare more affordable. We are pleased to add this important new product to our retail and wholesale customers' store brand product portfolios when we begin shipments to them for the upcoming cough/cold/flu season."
Tris Pharma is a technology driven specialty pharmaceutical company which pioneered sustained release in liquid and other unique dosage forms such as chewable/ODT and film strip.
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The Company's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia. Visit Perrigo on the Internet (http://www.perrigo.com).
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SOURCE Perrigo Company