14 December 2018 | News
Lupin receives tentative US FDA approval for Dimethyl Fumarate Delayed Release Capsules, 120 mg and 240 mg
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).