Healthcare Industry News:  Topiramate 

Biopharmaceuticals Generics FDA

 News Release - October 15, 2009

Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax(R) Sprinkle Capsules

PITTSBURGH, Oct. 15 (Healthcare Sales & Marketing Network) -- Mylan Inc. (Nasdaq: MYL ) today announced that its subsidiary 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.

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 the world's third largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.


Source: Mylan

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