Glenmark Pharma receives US FDA nod for seizure treatment drug

Glenmark Pharmaceuticals said Qudexy extended-release capsules market achieved annual sales of approximately US $120 mn

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.

Glenmark PharmaQudexy extended-releaseUpsher-Smith Laboratories
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