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.
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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.
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