Tentative OK for Teva's generic topiramate 50mg

13 March 2006

Israeli firm Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted tentative approval for its topiramate tablets, 50mg. Teva previously received tentative approval for the 25mg, 100mg and 200mg strengths of this drug product. Final approval is anticipated upon expiry of patent protection in September 2008.

On final approval, Teva's topiramate will be the AB-rated generic equivalent of Ortho McNeil's anticonvulsant Topamax.

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