Glenmark gets USFDA nod to market generic drug

New Delhi: Glenmark Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a medication used to treat and prevent seizures.

The company has received approval from the US Food and Drug Administration (USFDA) for Topiramate Capsules USP in 15 mg and 25 mg strengths, the Mumbai-based drug maker said in a statement. The company's product is therapeutically equivalent to Janssen Pharmaceuticals Inc's Topamax Capsules (15 mg and 25 mg), it added.

Glenmark said the drug will be distributed in the US market by Glenmark Pharmaceuticals Inc, USA. According to IQVIA sales data for the 12-month period ending May 2024, the Topamax capsules (15 mg and 25 mg) achieved annual sales of around USD 21.9 million. Glenmark's current portfolio consists of 198 products authorised for distribution in the US marketplace. The company said 50 abbreviated new drug applications (ANDAs) are currently pending for approval with the USFDA. Shares of Glenmark Pharmaceuticals were trading 0.88 per cent up at Rs 1,422.85 apiece on the BSE.