Sunday, 24 March 2019

Lupin receives tentative US FDA nod for multiple sclerosis drug

14 December 2018 | News

Lupin receives tentative US FDA approval for Dimethyl Fumarate Delayed Release Capsules, 120 mg and 240 mg

Representative Image

Representative Image

Pharma major Lupin has announced that it has received tentative approval for its Apixaban Tablets, 2.5 mg and 5 mg from the United States Food and Drug Administration (FDA) to market a generic version of Bristol-Myers Squibb Company's Eliquis® Tablets, 2.5 mg and 5 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 USD $3,545.4 million in the US (IQVIA MAT September 2018).

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