Category: Approval/Launch Region: Asia · India Company: Lupin Ltd

Lupin Receives US FDA Approval To Market Generic Tecfidera DR Capsules

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.

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