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Teva wins FDA approval for generic seizure drug

Israel-based Teva Pharmaceutical Industries, a generic pharmaceutical company, has received the FDA's approval for the company's abbreviated new drug application to market topiramate tablets. Shipment of the product has commenced.

The topiramate tablets are therapeutically equivalent to Topamax tablets from Ortho-McNeil Janssen Pharmaceuticals and are available in four strengths: 25mg, 50mg, 100mg and 200mg.

Topiramate is indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. It is also indicated as an adjunctive therapy for adults and pediatric patients aged two to 16 with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients two years of age or older with seizures associated with Lennox-Gastaut syndrome.