Glenmark gets USFDA approval for drugs on seizures
The US health authorities have given Glenmark Pharmaceuticals Ltd., an Indian pharmaceutical firm, a final license to use its generic Topiramate capsules for the treatment of specific seizure types. The Mumbai-based pharmaceutical business announced in a statement on Wednesday, July 17, that the US Food and Drug Administration (USFDA) has approved topiramate capsules with dosages of 15 mg and 25 mg.
The FDA determined that the 15 mg and 25 mg capsules of Glenmark's Topiramate USP were bioequivalent and therapeutically equivalent to the 15 mg and 25 mg capsules of Janssen Pharmaceuticals, Inc. It went on, saying that Glenmark's Topiramate capsules will be distributed in the US by Glenmark Pharmaceuticals Inc., USA. The company utilized IQVIATM sales data for the year that ended in May 2024 to estimate that the market for 15- and 25-milligram Topamax capsules witnessed annual sales of around USD 21.9 million.
According to the corporation, it now has 198 drugs licensed for distribution in the US market and 50 ANDAs (Abbreviated New Drug Applications) pending clearance from the US FDA.
