FDA gives Lupin’s generic Tecfidera tentative approval

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FDA gives Lupin’s generic Tecfidera tentative approval

By Sandra Levy - 12/13/2018
Lupin has received tentative approval from the Food and Drug Administration for dimethyl fumarate delayed-release capsules. The generic will be available in 120-mg and 240-mg dosage strengths.

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

Lupin’s generic is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

The product had a market value of roughly $3.5 billion, according to September 2018 IQVIA data.

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