September 8, 2024

Glenmark Pharma receives USFDA approval for a spasm treatment drug

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  • Glenmark Pharma stated it had obtained final permission from the US health regulator for Topiramate.
  • It treats several kinds of convulsions.

THDNewsDesk, New Delhi: On Wednesday, Drug major Glenmark Pharma stated it had obtained final permission from the US health regulator for Topiramate extended-release capsules to treat several kinds of convulsions.

The certified product is a general version of Qudexy XR Capsules of Upsher-Smith Laboratories, LLC.

Glenmark Pharmaceuticals Ltd has received final approval from the United States Food and Drug Administration (USFDA) for Topiramate extended-release capsules USP in the strengths of 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, Glenmark stated in a regulative filing.

Citing IQVIA sales data for the 12 months ended December 2020, Glenmark Pharmaceuticals said the Qudexy extended-release capsules market reached annual sales of roughly USD 120 million.

The company’s prevailing portfolio consists of 169 products approved for administration in the US market and 43 abbreviated new drug applications (ANDAs) pending permission with the USFDA.

Shares of Glenmark Pharmaceuticals were selling 2.41 percent higher at Rs 499.10 apiece on the BSE.

Source- Economic Times

Tags: Glenmark PharmaUSFDA

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