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news.Zydus Pharmaceuticals, a generic pharmaceutical company, has received final approval from the FDA for its abbreviated new drug application for topiramate tablets USP, 25mg, 50mg, 100mg, and 200mg.
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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.