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Aurobindo Receives FDA Approval for Dimethyl Fumarate Delayed-Release Capsules, 120mg and 240mg

Published: January 09, 2023

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.