Glenmark Pharma gets USFDA nod for seizure treatment drug

New Delhi: Drug major Glenmark Pharma on Wednesday said it 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 XR Capsules of Upsher-Smith Laboratories, LLC.

Glenmark Pharmaceuticals Ltd has received final approval from the United States Food and Drug Administration (USFDA) 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 USD 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 USFDA.

Shares of Glenmark Pharmaceuticals were trading 2.41 per cent higher at Rs 499.10 apiece on the BSE.