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.
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.