Pharmaceutical Business review

Zydus wins FDA approval for generic seizure drug

Topiramate tablets are indicated as an initial monotherapy in patients 10 years old or older with partial onset or primary generalized tonic-clonic seizures.

Topiramate tablets are 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. Topiramate tablets are the generic version of Ortho-McNeil-Janssen’s Topamax tablets.