Ranbaxy Laboratories Limited (Ranbaxy) has received an approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA), to market and manufacture topirimate tablets 25mg, 100mg & 200mg.
The application for the drug was submitted by Ranbaxy from the Ohm Laboratories manufacturing facility, located in North Brunswick, New Jersey, USA. The Office of Generic Drugs, US FDA, 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 Pharmaceuticals, Inc.
Topirimate tablets are indicated as adjunctive therapy for adults and paediatric patients ages two to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients two years of age and older with seizures associated with Lennox-Gastaut syndrome.
"Ranbaxy is pleased to receive this final approval for Topirimate tablets. This is the fourth ANDA approval granted to Ranbaxy that has materialized in 2009 that is specific to Ohm Laboratories," said Jim Meehan, vice president, Sales and Distribution, Ranbaxy Pharmaceuticals Inc, Jacksonville, Florida, USA.