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First Generic Topiramate Approved

The FDA has approved the first generic version of the epilepsy drug Topamax (topiramate).

The generic version of the drug will be available in 25 mg, 100 mg, and 200 mg tablets -- a 50 mg tablet was also tentatively approved.

Because the manufacturer, Mylan, was the first to file with the FDA, it will have a 180-day market exclusivity period, after which additional generic versions of the drug may be approved.

Link: Mylan press release (Free)

Link: Topamax prescribing information (Free PDF)

Published in Physician's First Watch September 14, 2006

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