Glenmark gets USFDA nod for multiple sclerosis medication

New Delhi, November 16

Glenmark Pharmaceuticals on Thursday said it had received approval from the US health regulator for Teriflunomide tablets used to treat multiple sclerosis.

The approved product is generic version of Sanofi-Aventis US’ Aubagio.

Glenmark Pharmaceuticals, USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Teriflunomide tablets in the strengths of 7 mg and 14 mg, the company said in a BSE filing.

Glenmark said with respect to 180-day generic drug exclusivity, it was one of the applicants to submit a substantially complete first abbreviated new drug application (ANDA) for Teriflunomide tablets.

“Therefore, with this approval, Glenmark is eligible for 180 days of shared generic drug exclusivity for Teriflunomide Tablets, 7 mg and 14 mg,” it added.

Citing IQVIA sales data for the 12-month period ending September 2018, the company said the Aubagio tablets market achieved annual sales of approximately USD 1.6 billion.

The company’s current portfolio consists of 142 products authorised for distribution at the US marketplace and 57 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA.

The company’s stock was trading at Rs 658.75 apiece, down 0.86 per cent, on the BSE. PTI