Zydus Lifesciences gets USFDA’s tentative approval for Diroximel Fumarate Delayed-Release Capsules

10 Jul 2024 Evaluate

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) to market Diroximel Fumarate Delayed-Release Capsules, 231 mg (USRLD: Vumerity Delayed-Release Capsulestablets). Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ, India. 

Diroximel Fumarate Delayed-Release Capsules had annual sales of $847.4 million in the United States (IQVIA MAT May 2024). The group now has 398 approvals and has so far filed over 460 ANDAs since the commencement of the filing process in FY 2003-04. 

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.


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