Corporate News     17-Jul-24
Glenmark receives USFDA approval for Topiramate Capsules

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (U.S. FDA) for Topiramate Capsules USP, 15 mg and 25 mg. Glenmark's Topiramate Capsules USP, 15 mg and 25 mg has been determined by the FDA to be bioequivalent and therapeutically equivalent1 to Topamax®2 Capsules, 15 mg and 25 mg of Janssen Pharmaceuticals, Inc., and will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIATM sales data for the 12-month period ending May 2024, the Topamax® Capsules, 15 mg and 25 mg market achieved annual sales of approximately $21.9 million.

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