Glenmark gets tentative FDA nod for generic Tecfidera

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Glenmark gets tentative FDA nod for generic Tecfidera

By Sandra Levy - 10/10/2019

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.

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