Ranbaxy gets USFDA approval for Topirimate tablets

Ranbaxy Laboratores has received an approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) to market and manufacture Topirimate tablets 25mg, l00mg & 200mg.

The Office of Generic Drugs, USFDA, has determined the Ranbaxy formulation to be bioequivalent and as having the same therapeutic effect as that of the reference listed drug, Topamax by Ortho McNeil Janssen Pharmaccuticals, Inc. The application for the drug was submitted by Ranbaxy from the Ohm Laboratories manufacturing facility, a wholly owned subsidiary of Ranbaxy Laboratories located in North Brunswick, New Jersey, USA.

Topirimate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2-16 years with partial onset seizures, or primary generalized tonic-clonic seiztires, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.

This is the fourth ANDA approval granted to Ranbaxy that has materialized in 2009 that is specific to Ohm Laboratories.