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Sun Pharma wins FDA approval for seizure drug

India-based Sun Pharmaceutical Industries has received the FDA's approval for its abbreviated new drug application to market generic Topamax, topiramate tablets.

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.