Glenmark Pharmaceuticals Receives USFDA Approval for Seizure Medication

Glenmark Pharmaceuticals announced on Thursday that it has received approval from the US health regulator to market a medication used to treat and prevent seizures.

The Mumbai-based pharmaceutical company secured approval from the US Food and Drug Administration (USFDA) for its Topiramate Capsules USP in 15 mg and 25 mg strengths, according to an official statement.

The product has been deemed therapeutically equivalent to Janssen Pharmaceuticals Inc's Topamax Capsules (15 mg and 25 mg), the company added.

Glenmark will distribute the drug in the US market through Glenmark Pharmaceuticals Inc, USA.

IQVIA sales data showed that Topamax capsules achieved annual sales of approximately USD 21.9 million for the 12-month period ending May 2024.

Glenmark's current US portfolio includes 198 products authorized for distribution, with an additional 50 abbreviated new drug applications (ANDAs) pending approval with the USFDA.

The company's shares were up 0.88% at Rs 1,422.85 on the BSE.

(With inputs from agencies.)