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Zydus Pharmaceuticals (USA) Inc. Announces FDA Final Approval for the Generic Version of Topamax(R) Tablets

Published in Medical Letter on the CDC and FDA, April 19th, 2009

Zydus Pharmaceuticals announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Tablets USP, 25mg, 50mg, 100mg, and 200mg. This product is available for immediate shipment.

Topiramate tablets are indicated as an initial monotherapy in patients 10 years old or older with partial onset or primary generalized tonic-clonic seizures. It is also indicated as an adjunctive therapy for adults and pediatric patients ages 2 - 16 with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age or older with seizures associated with...

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