Lupin gets US FDA approval for dimethyl fumarate delayed release capsules

Lupin has received approval for its dimethyl fumarate delayed-release capsules, 120 mg and 240 mg, from the United States Food and Drug Administration (US 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.

According to IQVIA MAT June 2020 data, dimethyl fumarate delayed-release capsules had an annual sales of approximately USD 3788 million in the US.