FDA Approved Mylan's Topiramate Capsules

Armen Hareyan's picture
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Mylan Pharmaceuticals has received tentative approval from FDA for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules, 15 mg and 25 mg.

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Topiramate Capsules are the generic version of Ortho McNeil Pharmaceuticals' Topamax Sprinkle Capsules which had U.S. sales of approximately $46 million for the 12 months ending June 30, 2007.

Mylan Laboratories Inc. is a leading pharmaceutical company with three
principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.

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