NEW DELHI, Oct 7: Drug major Glenmark Pharma on Wednesday said it 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 Inc’s Tecfidera delayed-release capsules.
Glenmark Pharmaceuticals Inc., USA, has been granted final approval by the United States Food and Drug Administration (USFDA) 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 USD 3.8 billion.
Glenmark said current portfolio consists of 164 products authorised for distribution in the US marketplace and 46 abbreviated new drug applications are pending approval with the USFDA.
(PTI)
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