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Topiramate - Conditional FDA Approval for Migraine

Posted by SLS on November 19, 2003, at 14:23:04

From Medscape:

"Topiramate Wins FDA's Conditional Migraine Approval

NEW YORK (Reuters) Nov 18 - U.S. regulators will approve Topamax (topiramate) as a preventive treatment for migraine headaches provided Johnson & Johnson provides additional analyses of its safety data, the company said on Tuesday.

The company said the U.S. Food and Drug Administration did not request additional clinical trials of the drug, which is currently approved as an adjunctive therapy for adults and children ages two to 16 with certain types of seizures.

The company said it will respond to the FDA's request for additional safety data analyses soon."

 

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