Cipla receives USFDA final approval for Dimethyl Fumarate DR Capsules

Cipla 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.

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