Glenmark gets USFDA approval for drugs on seizures

New Delhi: India based pharmaceutical company Glenmark Pharmaceuticals Ltd announced that it has received final approval from the US health regulator for its generic Topiramate capsules to be used for treating certain types of seizure.

On 17 July, Wednesday, the Mumbai based pharma company stated in a statement that the approval by the US Food and Drug Administration (USFDA) is for Topiramate capsules of strengths 15 mg and 25 mg.

The FDA found Glenmark's Topiramate USP, 15 mg, and 25 mg to be bioequivalent and therapeutically equivalent to Janssen Pharmaceuticals, Inc.'s Topamax, 15 mg, and 25 mg capsules. Glenmark Pharmaceuticals Inc., USA will distribute Glenmark's Topiramate capsules in the US, it continued. The market for 15- and 25-milligram Topamax capsules saw annual sales of about USD 21.9 million, according to the business, which used IQVIATM sales data for the year that concluded in May 2024.

The company said its current portfolio includes 50 ANDAs (Abbreviated New Drug Applications) that are awaiting USFDA approval and 198 medications that are licenced for distribution in the US market. According to the company, in order to enhance and expedite the expansion of its current pipeline and portfolio, it is still seeking out and investigating external development partnerships.

In order to meet the minimum public shareholding requirements, Glenmark Pharmaceuticals and Glen Saldanha, the company's promoters, stated last week that they would be offering up to a 7.85% stake in the business through an offer for sale (OFS).

Glenmark Pharma's stock has increased by 65% so far this year and has doubled over the previous 12 months. The company announced that its consolidated net loss for the March quarter increased to ₹1,238.6 crore from ₹549.4 crore during the same time last year.

Topiramate is used to treat specific types of seizures, such as partial onset seizures (seizures involving just one portion of the brain) and primary generalised tonic-clonic seizures (previously known as grand mal seizures; seizures involving the entire body). Topiramate can be taken alone or in combination with other drugs.

For those with Lennox-Gastaut syndrome (a disease that results in seizures and developmental delays), topiramate is also used in combination with other drugs to reduce seizures. In adults and children 12 years of age and older, topiramate is also used to prevent migraine headaches, although it does not lessen their discomfort. Topiramate belongs to the group of drugs known as anticonvulsants. It functions by reducing the brain's excessive excitation.