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Merck Emend 5-HT3 combo use

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's Gastrointestinal Drugs Advisory Committee agrees March 6 that Merck's Emend (aprepitant) can be used with any 5-HT3 antagonist to prevent chemotherapy-induced emesis, even though Merck did not study Emend in combo with all 5-HT3 agents. Committee votes 9-3 (one abstention) that available exposure data could be extrapolated to other dosage forms. The committee is unanimous on Emend's efficacy. If approved, Emend would be the first agent for the delayed phase of emesis (25-120 hours after chemotherapy); other anti-emetics are indicated only for the acute phase (up to 24 hours after chemo
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