Glenmark Pharma receives US FDA nod for seizure treatment drug

Glenmark Pharma has received final approval from the US health regulator for Topiramate extended-release capsules, used to treat certain types of seizures.

The approved product is a generic version of Qudexy capsules of Upsher-Smith Laboratories.

The company has received final approval from the United States Food and Drug Administration (US FDA) for Topiramate extended-release capsules USP in the strengths of 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, Glenmark said in a regulatory filing.

Quoting IQVIA sales data for the 12-month period ended December 2020, Glenmark Pharmaceuticals said Qudexy extended-release capsules market achieved annual sales of approximately US $120 million.

The company’s current portfolio consists of 169 products authorised for distribution in the US market and 43 abbreviated new drug applications (ANDAs) pending approval with the US FDA.