Glenmark gets tentative FDA nod for generic Tecfidera

Glenmark has received the Food and Drug Administration’s tentative approval for dimethyl fumarate delayed-release capsules, in dosage strengths of 120 mg and 240 mg.

The product is the generic of Biogen’s Tecfidera capsules, 120 mg and 240 mg. .

Tecfidera capsules, 120 mg and 240 mg had a market value of approximately $3.7 billion for the 12 months ended in August 2019, according to IQVIA.