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Aloxi Superiority Disclaimer Is Based On Advantage In Only 1 Of 3 Pivotals

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Aloxi’s labeling statement on the lack of superiority of the antiemetic to other 5-HT3 antagonists is based on the fact that only one of MGI/Helsinn’s three pivotal trials showed a statistical advantage in preventing acute chemotherapy-induced nausea, FDA review documents show.

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