Lupin receives tentative USFDA nod for Dimethyl Fumarate Delayed-Release Capsules
New Delhi: 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 relapsing forms of multiple sclerosis. It helps to decrease the number of episodes of worsening 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).
Tecfidera belongs to a group of drugs called Nrf2 activators. It is thought to work by decreasing inflammation and preventing nerve damage that can lead to symptoms of multiple sclerosis.
Lupin is a pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.
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