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25 Jan 2011

FDA Approves Mylan's Treatment for Esophagus

Mylan's Matrix Laboratories Limited has received approval from the U.S. FDA for its generic version of Wyeth's Protonix? DR Tablets.

Matrix Laboratories, a subsidiary of Mylan, has received approval for its abbreviated new drug application (ANDA) from the FDA for Pantoprazole Sodium delayed-release (DR) tablets USP, 20mg (base) and 40mg (base) to treat irritation of the esophagus.


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 t

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