Glenmark gets USFDA nod for seizure treatment drug

PTI New Delhi | Updated on January 24, 2019 Published on January 24, 2019

Glenmark Pharmaceuticals has received a tentative nod 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 Upsher-Smith Laboratories, LLC’s QUDEXY XR extended release capsules.

Glenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food and Drug Administration for Topiramate extended release capsules in the strength of 25 mg, 50 mg, 100 mg, 150 mg and 200 mg, the company said in a BSE filing on Thursday. Quoting IQVIA sales data for the 12-month period ended November 2018, Glenmark Pharmaceuticals said, QUDEXY XR extended release capsules market achieved annual sales of approximately $ 84 million.

The company’s current portfolio consists of 148 products authorised for distribution in the US market and 54 abbreviated new drug applications (ANDAs) pending approval with the USFDA. Shares of Glenmark Pharmaceuticals were trading 1.02 per cent higher at Rs 656.10 apiece on the BSE.

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Published on January 24, 2019
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