Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax® Sprinkle Capsules

PITTSBURGH -- Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules (Sprinkle), 15 mg and 25 mg.

Topiramate Capsules (Sprinkle) are the generic version of Ortho McNeil's anticonvulsant Topamax® Sprinkle Capsules, 15 mg and 25 mg. For the 12 months ending June 30, 2009, Topiramate Capsules (Sprinkle) had U.S. sales of approximately $58 million for the same strengths, according to IMS Health. Mylan has launched this product.

Currently, Mylan has 121 ANDAs pending FDA approval representing $85.7 billion in annual brand sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $17.9 billion in annual brand sales, according to IMS Health.


With headquarters in Pittsburgh, Mylan maintains a large production facility in Morgantown. Mylan is the 11th largest private company in West Virginia in 2009, according to data recently released by Workforce West Virginia.

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. For more information, please visit www.mylan.com.