Lupin receives USFDA tentative approval for Dimethyl Fumarate Delayed Release Capsules

Lupin announced that it has received tentative approval for its Dimethyl Fumarate Delayed Release Capsules, 120 mg and 240 mg from the United States Food and Drug Administration (FDA).

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 re lapsing forms of multiple sclerosis.

Tecfidera Capsules, 120 mg and 240 mg had annual sales of approximately USD $3,545.4 mil lion in the US (IQVIA MAT September 2018).

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