Date: 07-Oct-2020

Lupin Receives US FDA Approval To Market Generic Tecfidera DR Capsules

Pharma major Lupin Limited has received approval for its dimethyl fumarate delayed-release capsules, 120 mg and 240 mg, from the United States Food and Drug Administration (FDA), to market a generic equivalent of Tecfidera delayed-release capsules, 120 mg and 240 mg, of Biogen, Inc.

The product is expected to be launched shortly.

Dimethyl fumarate delayed-release capsules, 120 mg and 240 mg, are indicated for the treatment of patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Dimethyl fumarate delayed-release capsules had an annual sales of approximately US$ 3788 million in the US, according to IQVIA MAT June 2020.