US FDA approves Aloxi(R) (Palonosetron HCL) Injection for Prevention of Postoperative Nausea and Vomiting
Eisai Corporation of North America, its U.S. subsidiary, MGI PHARMA, INC., and Helsinn Healthcare SA said that U.S. Food and Drug Administration (FDA) has approved Aloxi® (palonosetron hydrochloride) injection for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
Aloxi, is the first and only 5-hydroxytryptamine-3 (5-HT3) receptor antagonist approved by the FDA for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.
"This is an important milestone for Aloxi, given the increasing use of antiemetic prophylaxis during surgical procedures," said Riccardo Braglia, CEO, Helsinn Healthcare SA, a privately owned Swiss pharmaceutical group, holder of the Aloxi New Drug Application and partner of Eisai Corporation of North America. MGI PHARMA, INC. licensed the North American distribution and marketing rights for Aloxi from Helsinn.