The approved product is a generic version of Upsher-Smith Laboratories’ QUDEXY XR extended release capsules
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’ QUDEXY XR extended release capsules. Glenmark Pharmaceuticals 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.
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 US FDA.