India-based Sun Pharmaceutical Industries has received the FDA's approval for its abbreviated new drug application to market generic Topamax, topiramate tablets.
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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, an anticonvulsant, 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 adjunctive therapy for adults and pediatric patients aged two to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients two years of age and older with seizures associated with Lennox-Gastaut syndrome.
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