(dailyRx)

Zydus Pharmaceuticals has announced that it received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for the anti-seizure medication topiramate tablets.

This product, the generic version of Ortho-McNeil-Janssen's Topamax tablets, is available for immediate shipment. Zydus Pharmaceuticals' topiramate tablets are available in 25 mg, 50 mg, 100 mg and 200 mg strengths.

Topiramate tablets are indicated as an initial monotherapy in patients 10 years and older with partial onset or primary generalized tonic-clonic seizures. The drug is also indicated as an adjunctive therapy for adults and pediatric patients ages 2 to 16 with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years and older with seizures associated with Lennox-Gastaut syndrome.

Contact:
Mike Keenley
609-275-5125