Zydus Lifesciences bags USFDA tentative nod for multiple sclerosis drug
Ahmedabad: Zydus Lifesciences Limited has announced that the Company 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 Fumarate Delayed-Release Capsules are indicated for the treatment of relapsing forms of multiple sclerosis in adults.
Relapsing forms of multiple sclerosis encompass conditions where patients experience intermittent exacerbations of neurological symptoms followed by periods of partial or complete recovery.
The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ, India.
Medical Dialogues team had earlier reported that Zydus Lifesciences Limited had received final approvals from the USFDA to manufacture and market Dexamethasone Tablets USP, 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg (USRLD: Decadron Tablets) and Dexamethasone Tablets USP, 2 mg (USRLD: Dexamethasone Tablets).
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 398 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.
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Headquartered in Ahmedabad, Zydus Lifesciences Limited is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer-related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs.
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