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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application topiramate capsules USP, 15mg and 25mg. Aurobindo Pharma’s topiramate capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Topamax Capsules, manufactured by Janssen Pharmaceuticals.
Topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. They are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. They are also Indicated for the preventive treatment of migraine in patients 12 years of age and older
Topiramate capsules has an estimated market size of US $76.2 million for the twelve months ending July 2023, as per IQVIA.
