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).
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