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

Deepthi | Myequity news | Date : 13-12-2018 17:00:00 IST

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 (FDA) to market a 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).

About Lupin Limited:

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.


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