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Cipla will get last nod from USFDA for a number of sclerosis drug – Home Health Choices

New Delhi: Drug main Cipla on Friday mentioned it has acquired last approval from the US well being regulator for Dimethyl Fumarate capsules, indicated for the therapy of relapsing types of a number of sclerosis. The newly permitted product is a generic therapeutic equal model of Biogen IDEC Inc’s Tecfidera.

Cipla has acquired last approval for its abbreviated new drug utility (ANDA) for Dimethyl Fumarate DR (delayed launch) capsules within the strengths of 120mg, 240mg and 120mg and 240mg from the United States Food and Drug Administration (USFDA), the corporate mentioned in a regulatory submitting.

Quoting IQVIA (IMS Health) information, Cipla mentioned Tecfidera had US gross sales of roughly USD three.eight billion for the 12-month interval ending July 2020.

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