Helsinn and MGI Pharma Announce sNDA for Aloxi Capsules Accepted for Review by U.S. FDA.
PR Newswire Europe, January, 2008
LUGANO, Switzerland, January 3 /PRNewswire/ -- Helsinn Healthcare S.A., Switzerland, a privately owned pharmaceutical group and its partner, MGI Pharma (Nasdaq: MOGN), a biopharmaceutical company focused in oncology and acute care, today announced that a supplemental New Drug Application (sNDA) for Aloxi(R) (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...
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