Aloxi receives FDA approval. (News).(Brief Article)

Chemical Market Reporter, August, 2003

MGI PHARMA and Helsinn Healthcare SA have announced Food and Drug Administration (FDA) approval of Aloxi (palonosetron), the first 5-HT-3 receptor antagonist to be indicated for the prevention of delayed chemotherapy-induced nausea and vomiting caused by moderately ematogenic cancer chemotherapy.

Sales in the first 12 months after launch could range from $40 million to $55 million, according to MGI, which projects annual sales of up to $250 million in four years. The active ingredient is being manufactured in Biasca, Switzerland, by Helsinn Chemicals SA and Helsinn Advanced Synthesis SA, which recently received prenotification approval from the FDA. Helsinn Advanced Synthesis is Helsinn's highly potent active ingredients unit.