Zydus Lifesciences Gets USFDA Nod for Multiple Sclerosis Drug

Zydus Lifesciences Ltd. said it has received final approval from the US Food and Drug Administration for diroximel fumarate delayed-release capsules of 231-milligram strength. The capsules are used to treat relapsing forms of multiple sclerosis in adults and will be manufactured at the company’s SEZ facility.

According to IQVIA data for September 2025, the approved drug had annual sales of $999.4 million in the US. As of September 30, the group had secured 426 approvals and filed 487 abbreviated new drug applications.