The US Food and Drug Administration has granted tentative approval for Teva Pharmaceutical Industries' Topiramate Tablets, 50 mg. Teva previously received tentative approval for the 25 mg, 100 mg and 200 mg strengths of this drug product. Final approval is anticipated upon expiry of patent protection in September 2008.
Upon final approval, Teva's Topiramate Tablets will be the AB-rated generic equivalent of Ortho McNeil's anticonvulsant Topamax Tablets.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company.