Lupin gets USFDA nod to generic equivalent of Tecfidera Delayed-Release Capsules
Mumbai, Baltimore: Pharma major, Lupin Limited, has recently announced that the company has received approval for its Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, from the United States Food and Drug Administration (U.S. 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 (RLD: Tecfidera) had an annual sales of approximately USD 3788 million in the U.S. (IQVIA MAT June 2020).
The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.