USFDA13 Nov 2025, 04:55 pm
Zydus Lifesciences Receives Final USFDA Approval for Diroximel Fumarate Delayed-Release Capsules
AI Summary
Zydus Lifesciences Limited has received final approval from the USFDA for Diroximel Fumarate delayed-release capsules, 231 mg. The capsules are indicated for the treatment of relapsing forms of multiple sclerosis in adults and will be produced at Zydus Lifesciences Ltd, SEZ. The group now has 426 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04. The product had annual sales of USD 999.4 mn in the United States (IQVIA MAT Sept-2025).
Key Highlights
- Zydus Lifesciences receives final approval from USFDA for Diroximel Fumarate Delayed-Release Capsules, 231 mg
- Indicated for the treatment of relapsing forms of multiple sclerosis in adults
- To be produced at Zydus Lifesciences Ltd, SEZ
- Product had annual sales of USD 999.4 mn in the United States (IQVIA MAT Sept-2025)
- Zydus now has 426 approvals and has so far filed 487 ANDAs