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Aurobindo gets FDA approval for dimethyl fumarate delayed-release capsules

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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Dimethyl Fumarate Delayed-Release Capsules, 120mg and 240mg. Aurobindo Pharma’s Dimethyl Fumarate Delayed-Release Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), TECFIDERA Delayed-Release Capsules manufactured by BIOGEN Inc.

Dimethyl Fumarate Delayed-Release Capsules, are indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Dimethyl Fumarate Delayed-Release Capsules, has an estimated market size of US $771 Million for the twelve months ending November 2022, as per IQVIA.


ECRM_06-01-22


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