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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.
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