Glenmark’s generic drug to treat multiple sclerosis gets tentative nod from USFDA

PTI New Delhi | Updated on October 09, 2019 Published on October 09, 2019

Glenmark Pharmaceuticals on Wednesday said it has received tentative nod from the US health regulator for dimethyl fumarate delayed-release capsules used for treating multiple sclerosis.

The tentative nod granted by the US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc, USA is for multiple strengths of dimethyl fumarate delayed-release capsules of 120 mg and 240 mg.

These are generic versions of Tecfidera Capsules, 120 mg and 240 mg, of Biogen Inc, Glenmark Pharmaceuticals said in a statement.

Citing IQVIATM sales data for the 12-month period ending August 2019, the company said Tecfidera Capsules, 120 mg and 240 mg achieved annual sales of approximately $3.7 billion.

Glenmark said its current portfolio consists of 161 products authorised for distribution in the US market and 49 abbreviated new drug applications (ANDAs) pending approval with the USFDA.

Published on October 09, 2019
This article is closed for comments.
Please Email the Editor