A supplemental New Drug Application (sNDA) has been submitted to the United States Food and Drug Administration (FDA) by MGI Pharma Inc., and Helsinn Healthcare SA for their agent Aloxi (palonosetron). Aloxi is a 5-HT3 receptor antagonist.
The sNDA has been submitted for oral administration of Aloxi, versus the already approved intravenous formulation. Aloxi is approved for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
The sNDA submission was based on a non-inferiority trial comparing oral and intravenous formulations of Aloxi.
© 1998-2007 OncoEd.com All Rights Reserved.
These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.
Patient Home
