Glenmark Pharmaceuticals Ltd on Wednesday said it has received final approval from the US health regulator for its generic Topiramate capsules used to treat certain types of seizure.
The approval by the US Food & Drug Administration (USFDA) is for Topiramate capsules of strengths 15 mg and 25 mg, Glenmark Pharmaceuticals said in a statement.
Glenmark's Topiramate capsules USP, 15 mg and 25 mg have 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 US by Glenmark Pharmaceuticals Inc., USA, it added.
Topamax Capsules, 15 mg and 25 mg market achieved annual sales of approximately USD 21.9 million, the company said citing IQVIATM sales data for the 12-month period ended May 2024.
The company said its current portfolio consists of 198 products authorised for distribution in the US marketplace and 50 ANDAs (Abbreviated New Drug Applications) pending approval with the USFDA.
The company said it continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
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