BRIEF—US FDA approves Zydus’ delayed-release capsules for MS
India’s Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) for diroximel fumarate delayed-release capsules, 231mg (Biogen’s Vumerity delayed-release capsules, 231mg).
Diroximel fumarate delayed-release capsules, 231mg, are indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Diroximel fumarate delayed-release capsules will be produced at Zydus Lifesciences, SEZ.
Diroximel fumarate delayed-release capsules had annual sales of $999.4 million in the USA (IQVIA MAT Sept-2025).
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