News
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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