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Glenmark Pharma gets US FDA nod for seizure treatment drug

The approved product is a generic version of Qudexy XR Capsules of Upsher-Smith Laboratories

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

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

Glenmark Pharmaceuticals 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 months ended December 2020, Glenmark Pharmaceuticals said Qudexy extended-release capsules market achieved annual sales of approximately $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.

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