New Delhi, Oct 10 (UNI) Glenmark Pharmaceuticals Ltd today said it has received final approval from the US Food and Drug Administration (FDA) for marketing Oxcarbazapine.
The first generic version of Trileptal, Oxcarbazapine tablets will be availbale in the strengths of - 150 mg, 300 mg and 600 mg, a statement said.
Trileptal is a widely used medication to treat epilepsy that has FDA approval.
With this approval, GPI now has a portfolio of 20 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process.
The company was one of the first ANDA applicants to submit a Paragraph IV certification to the '525 patent'. Therefore, with this approval, the company has been awarded for 180 days of shared generic drug exclusivity for these strengths.