Zydus receives tentative approval from USFDA for Diroximel Fumarate Delayed-Release Capsules, 231 mg

Zydus receives tentative approval from USFDA for Diroximel Fumarate Delayed-Release Capsules, 231 mg Ahmedabad, India, 10 July, 2024 Zydus Lifesciences Limited (including its subsidiaries/ affiliates , hereafter referred to as “Zydus”) 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 Capsules tablets). Diroximel Fum arate 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 USD 847.4 mn in the United States (IQVIA MAT May 2024). The group now has 39 8 approvals and has so far filed over 4 60* ANDAs since the commencement of the filing process in FY 2003-04. (*as of 31st March 2024) ****

The release as fetched from its publisher. zyduslife.com ↗