MGI PHARMA, INC. and Helsinn Healthcare SA Announce sNDA for Aloxi Capsules Accepted for Review by U.S FDA

Published: Jan 03, 2008

MINNEAPOLIS & LUGANO, Switzerland--(BUSINESS WIRE)--MGI PHARMA, INC. (Nasdaq:MOGN), a biopharmaceutical company focused in oncology and acute care, and its partner HELSINN HEALTHCARE SA, a privately owned Swiss pharmaceutical group, today announced that a supplemental New Drug Application (sNDA) for Aloxi® (palonosetron hydrochloride) Capsules for oral administration was accepted for filing by the U.S. Food and Drug Administration (FDA). Aloxi Injection is approved by the FDA 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.

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