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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.
Also read: Glenmark to launch higher strength Favipiravir to reduce pill-burden to patients
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 (ANDAs) pending approval with the USFDA.
Shares of Glenmark Pharma were trading at ₹494.85 per scrip on the BSE, up 0.94 per cent over the previous close.
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