Zydus gains USFDA approval for multiple sclerosis treatment

Zydus Lifesciences Limited announced on November 13, 2025, that it has received final approval from the USFDA for Diroximel Fumarate delayed-release capsules, 231 mg. This product is indicated for treating relapsing forms of multiple sclerosis (MS) in adults and will be manufactured at Zydus Lifesciences Ltd, SEZ.

The approved capsules are the generic equivalent to Vumerity Delayed-Release Capsules, 231 mg. Diroximel fumarate delayed-release capsules recorded annual sales of $999.4m in the United States as of September 2025 (IQVIA MAT Sept-2025).

This latest approval marks the 426th for the Zydus group, which has filed 487 Abbreviated New Drug Applications (ANDAs) since initiating its filing process in fiscal year 2003-04.