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Mylan's Matrix Receives Approval for Generic Version of Protonix® Delayed-release Tablets

Mon, 01/24/2011 - 11:34am
Bio-Medicine.Org

PITTSBURGH, Jan. 24, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium Delayed-release (DR) Tablets USP, 20 mg (base) and 40 mg (base), the generic version of Wyeth's Protonix® DR Tablets, a treatment for the irritation of the esophagus caused by gastroesophageal reflux disease (GERD).

Pantoprazole Sodium DR Tablets had U.S. sales of approximately $1.7 billion for the 12 months ending Sept. 30, 2010, according to IMS Health. Mylan Pharmaceuticals Inc. is shipping this product immediately.

Currently, Mylan has 170 ANDAs pending FDA approval representing $97.8 billion in annual sales, according to IMS Health. Forty-six of these pending ANDAs are potential first-to-file opportunities, representing $24.3 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit www.mylan.com.

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