Glenmark Pharmaceuticals Ltd. on Wednesday announced that it has received final approval from the United States Food & Drug Administration (U.S. FDA) for Topiramate Capsules USP, 15 mg and 25 mg.
According to the company’s press statement, Glenmark’s Topiramate Capsules USP, 15 mg and 25 mg has been determined by the FDA to be bioequivalent and therapeutically equivalent to Topamax 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.
The drug is prescribed to treat epilepsy by preventing and managing seizures.
Glenmark’s current portfolio consists of 198 products authorized for distribution in the U.S. marketplace and 50 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, the company said in a statement.
