Epilepsy

Company receives tentative approval for generic Topiramate tablets

Published in Medical Letter on the CDC and FDA, November 2nd, 2003

IVAX Corp. (IVX) has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Topiramate tablets in 25 mg, 100 mg, and 200 mg strengths.

Upon final approval, this product will be sold through the company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc. Topiramate is the generic equivalent of Topamax, which is marketed by Ortho-McNeil as an antiepileptic drug to control both partial and grand-mal seizures. U.S. sales of Topamax tablets in the 25, 100, and 200 mg dosage strengths were over $785 million for the past 12 months ending in the second quarter of 2003.

IVAX continues its...

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Source: Medical Letter on the CDC and FDA (2003-11-02)

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