Cipla gets final nod from USFDA for multiple sclerosis drug

Drug major Cipla on Friday said it has received final approval from the US health regulator for Dimethyl Fumarate capsules, indicated for the treatment of relapsing forms of multiple sclerosis. The newly approved product is a generic therapeutic equivalent version of Biogen IDEC Inc’s Tecfidera.

Cipla has received final approval for its abbreviated new drug application (ANDA) for Dimethyl Fumarate DR (delayed release) capsules in the strengths of 120mg, 240mg and 120mg and 240mg from the United States Food and Drug Administration (USFDA), the company said in a regulatory filing.

Quoting IQVIA (IMS Health) data, Cipla said Tecfidera had US sales of approximately USD 3.8 billion for the 12-month period ending July 2020. Shares of Cipla were trading 2.12 percent higher at Rs 748.35 apiece on the BSE.

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