Mylan gets FDA approval for generic Topamax

By Lisa Kerner

Charlotte, N.C., Sept. 12 - Mylan Pharmaceuticals, Inc. received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for Topiramate tablets (25 mg, 100 mg and 200 mg), the generic version of Ortho-McNeil's Topamax tablets for migraine prevention.

The FDA granted tentative approval for Topiramate 50 mg strength and 180 days of market exclusivity for the 25 mg, 100 mg and 200 mg strengths.

Topamax had U.S. sales of approximately $1.37 billion for the three strengths approved for the 12-month period ended June 30, according to IMS Health.

Mylan is a subsidiary of Mylan Laboratories, Inc., a Pittsburgh-based pharmaceutical company.

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