Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Dimethyl Fumarate DR Capsules 120mg, 240mg and 120mg/240mg Starter Pak from the United States Food and Drug Administration (FDA).
Cipla's Dimethyl Fumarate DR Caps 120mg, 240mg and 120mg/240mg Starter Pak is AB-rated generic therapeutic equivalent version of Biogen IDEC's Tecfidera®. It is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
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According to IQVIA (IMS Health), Tecfidera® had US sales of approximately $3.8 Billion for the 12-month period ending July 2020.