Lupin gets USFDA’s tentative approval for Dimethyl Fumarate Delayed Release Capsules

13 Dec 2018 Evaluate

Lupin has received tentative approval for its Dimethyl Fumarate Delayed Release Capsules, 120 mg and 240 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Biogen, Inc's Tecfidera Capsules, 120 mg and 240 mg.

Lupin's Dimethyl Fumarate Delayed Release Capsules, 120 mg and 240 mg is the generic version of Biogen, Inc's Tecfidera Capsules, 120 mg and 240 mg. It is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Tecfidera Capsules, 120 mg and 240 mg had annual sales of approximately $3,545.4 million in the US (IQVIA MAT September 2018).

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

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