|New Delhi: Ranbaxy Laboratories has received approval from the US Food and Drug Administration (USFDA) to market and manufacture a generic drug for treating seizures. |
The company has received approvals for Topirimate tablets which have the same therapeutic effect as that of the reference listed drug, Topamax by Ortho McNeil Janssen Pharmaceuticals Inc.
The application for the drug was submitted by Ranbaxy from the Ohm Laboratories manufacturing facility, located in North Brunswick, New Jersey, USA.
Ohm is a wholly owned subsidiary of Ranbaxy Laboratories Ltd. Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the US healthcare system. Facing data falsification charges from the USFDA at one of its Indian facilities, Ranbaxy is now relying upon the drug making capabilities of its US subsidiary, Ohm Laboratories.
This is the fourth drug approval received by Ranbaxy after the USFDA banned drugs from the company’s plant in Paonta Sahib. It had earlier got approval to market cardiovascular drug — Ramipril Capsules, generic version of Pfizer’s blood pressure drug Accuretic and GSK’s blockbuster migrane medicine, Imetrix.