Glenmark obtains FDA OK for generic Tecfidera

The Food and Drug Administration has given the green light to Glenmark for dimethyl fumarate delayed-release capsules, in dosage strengths of 120 mg and 240 mg.

The product is the generic of Biogen’s Tecfidera delayed-release capsules. It is indicated for adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. 

Tecfidera had a market value of approximately $3.8 billion for the 12-month period ending August, according to IQVIA.