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.
New Delhi: 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.
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.