Zydus Pharmaceuticals (USA) Inc. Announces FDA Final Approval for the Generic Version...

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

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.

Mike Keenley of Zydus Pharmaceuticals (USA) Inc., +1-609-275-5125