The drug is indicated to treat relapsing forms of multiple sclerosis
Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration (US FDA) for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, a generic version of Tecfidera Capsules, 120 mg and 240 mg, of Biogen Inc. The drug is indicated to treat relapsing forms of multiple sclerosis.
According to IQVIATM sales data for the 12 month period ending August 2019, the Tecfidera Capsules, 120 mg and 240 mg market achieved annual sales of approximately $3.7 billion.
Glenmark’s current portfolio consists of 161 products authorised for distribution in the US marketplace and 49 ANDA’s pending approval with the US FDA.
- Advertisement -