Zydus receives tentative approval from USFDA for Diroximel Fumarate DR Capsules

Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis

Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) to market Diroximel Fumarate Delayed-Release Capsules, 231 mg.

Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ, India.

Diroximel Fumarate Delayed-Release Capsules had annual sales of USD 847.4 mn in the United States (IQVIA MAT May 2024).