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news.Eisai, its US subsidiary MGI Pharma, and Helsinn Healthcare have reported that the FDA has approved Aloxi injection for the prevention of postoperative nausea and vomiting or PONV for up to 24 hours following surgery.
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The new indication is based on one double-blind Phase III study that evaluated the efficacy of three doses of Aloxi compared to placebo for the prevention of PONV. Efficacy beyond 24 hours has not been demonstrated.
Hajime Shimizu, chairman and CEO of Eisai of North America, said: “A single intravenous dose of Aloxi can provide anesthesiologists with an effective option for the prevention of PONV for up to 24 hours.”