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Last updated on April 19, 2014 at 9:20 EDT

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

March 27, 2009

PRINCETON, N.J., March 27 /PRNewswire/ — Zydus Pharmaceuticals announced today 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 Lennox-Gastaut syndrome. Topiramate tablets are the generic version of Ortho-McNeil-Janssen’s Topamax(R) Tablets and according to Wolters Kluwer Health (formerly NDC Health) that product had sales over $3.2 billion for the 12 months ending February 28, 2009.

Zydus Pharmaceuticals (USA) Inc., located in Princeton, N.J., is the U.S. division of Cadila Healthcare. Cadila Healthcare is India’s 4th largest pharmaceutical company and has a presence in over 50 countries worldwide. This is Zydus Pharmaceutical’s 42nd tentative or final approval over the last four years. For more information on Zydus Pharmaceuticals please visit our website at www.zydususa.com.

SOURCE Zydus Pharmaceuticals (USA) Inc.


Source: newswire