Zydus multiple sclerosis drug Diroximel Fumarate delayed release gets tentative USFDA okay
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-11-13 09:33 GMT | Update On 2025-11-13 09:33 GMT
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Ahmedabad: Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for Diroximel Fumarate delayed-release capsules, 231 mg (USRLD: Vumerity Delayed-Release Capsules, 231 mg).
Diroximel fumarate delayed-release capsules, 231 mg, are indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults.
Diroximel fumarate delayed-release capsules will be produced at
Diroximel fumarate delayed-release capsules had annual sales of USD 999.4 mn in the United States (IQVIA MAT Sept-2025).
The group now has 426 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences Ltd. is a global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and New Chemical Entities.
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