MGI PHARMA, INC. and Helsinn Healthcare SA Announce Submission of Supplemental New Drug Application for Aloxi(R) Capsules

MINNEAPOLIS & LUGANO, Switzerland--(BUSINESS WIRE)--MGI PHARMA, INC. (Nasdaq:MOGN - News), 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 has been submitted to 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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