Glenmark Pharmaceuticals has received final approval from the United States Food & Drug Administration (USFDA) for its Topiramate Capsules USP, 15 mg and 25 mg, indicated for the treatment of epilepsy and seizures, the company informed stock exchanges on July 17.

The FDA considers Topiramate capsules USP bioequivalent and therapeutically equivalent to a drug by Janssen Pharmaceuticals. According to the latest IQVIATM sales data, the market for Topamax capsules has reached approximately $21.9 million in annual sales.

Glenmark Pharma’s current US portfolio includes 198 products authorised for distribution and 50 abbreviated new drug applications (ANDAs) pending USFDA approval.

Shares of Glenmark Pharma have risen by 65% so far this year and have doubled in the past year.

The company reported a widening consolidated net loss to Rs 1,238.6 crore for the March quarter, compared to a net loss of Rs 549.4 crore in the same period a year ago.

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