Mylan receives tentative FDA approval for Topiramate capsules

Sep 11 2007

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

Topiramate Capsules are the generic version of Ortho McNeil Pharmaceuticals' Topamax(R) 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.