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Aurobindo Receives FDA Approval for Topiramate Capsules USP, 15 mg and 25 mg

Published: September 27, 2023

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, 15 mg and 25 mg. Aurobindo Pharma’s Topiramate Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Topamax® Sprinkle Capsules manufactured by Janssen Pharmaceuticals, Inc.

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
  • 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
  • For the preventive treatment of migraine in patients 12 years of age and older.