FDA approves Matrix's generic Protonix DR Tablets ANDA

Jan 25 2011

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.