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 approval of a supplemental New Drug Application (sNDA) for Aloxi® (palonosetron hydrochloride) Injection by the United States Food and Drug Administration (FDA). This sNDA includes the removal of a dosing recommendation, which limited Aloxi use to once per seven day interval, from the product’s label. Data from several safety and efficacy trials that evaluated multiple day dosing of Aloxi were included in the sNDA. 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.
