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Generic Tecfidera Delayed Release Approved

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    Generic Tecfidera Delayed Release Approved

    Drug firm Zydus Cadila on Friday said it has received final approval from the US health regulator to market Dimethyl Fumarate delayed-release capsules, indicated for the treatment of patients with relapsing forms of multiple sclerosis. Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Dimethyl Fumarate delayed release capsules, (Tecfidera)in the strengths of 120 mg and 240 mg, Zydus Cadila, part of Cadila Healthcare group, said in a regulatory filing.

    https://www.cnbctv18.com/healthcare/...g-7016441.htm?


    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.

    https://www.cnbctv18.com/healthcare/...ug-7016461.htm
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