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 http://www.zydususa.com.
