Glenmark Pharma gets nod to market relapsing multiple sclerosis drug
The approved product is a generic version of Biogen’s Tecfidera delayed-release capsules
Glenmark Pharma has received final approval from the US health regulator for Dimethyl Fumarate delayed-release capsules, used for treatment of relapsing forms of multiple sclerosis in adults.
The approved product is a generic version of Biogen’s Tecfidera delayed-release capsules.
Glenmark Pharmaceuticals, has been granted final approval by the United States Food and Drug Administration (US FDA) for Dimethyl Fumarate delayed-release capsules in the strengths of 120 mg and 240 mg, Glenmark said in a regulatory filing.
Quoting IQVIA sales data for the 12 month period ending August 2020, Glenmark said Tecfidera delayed-release capsules, 120 mg and 240 mg, market achieved annual sales of approximately $3.8 billion.
Glenmark said the current portfolio consists of 164 products authorised for distribution in the US marketplace and 46 abbreviated new drug applications are pending approval with the US FDA.
