Cipla Limited today announced that it 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 (US FDA).
Cipla’s Dimethyl Fumarate DR Caps 120mg, 240mg and 120mg/240mg Starter Pak is AB-rated generic therapeutic equivalent version of Biogen IDEC Inc.’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.
According to IQVIA (IMS Health), Tecfidera® had US sales of approximately $3.8 Billion for the 12-month period ending July 2020.
The product is available for shipping immediately. Cipla will providing Co-Pay Assistance.