Helsinn passes FDA inspection for palonosetron manufacturing

Published: 17-Jul-2003

Swiss-based Helsinn\'s manufacturing site for its new antiemetic drug palonosetron has passed a pre-approval inspection by the US FDA.


Swiss-based Helsinn's manufacturing site for its new antiemetic drug palonosetron has passed a pre-approval inspection by the US FDA.

Palonosetron (US trademark Aloxi) is a potent, highly selective 5-HT3 receptor antagonist with a strong receptor-binding affinity, a long plasma half-life, and an extended duration of activity. It has been developed for the prevention of chemotherapy-induced nausea and vomiting (CINV).

The palonosetron NDA is currently undergoing FDA review and once approved for marketing, it will be launched by Helsinn's US partner MGI PHARMA, an oncology-focused biopharmaceutical company based in Minneapolis, Minnesota.

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