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

MINNEAPOLIS--(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 the supplemental New Drug Application (sNDA) for Aloxi® (palonosetron hydrochloride) Injection for the prevention of post-operative nausea and vomiting was accepted for filing by the United States Food and Drug Administration (FDA). Aloxi 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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