Lupin gets US FDA approval for dimethyl fumarate delayed release capsules
It is indicated for the treatment of patients with relapsing forms of multiple sclerosis
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.
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