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Redux returning to FDA advisory committee in November; Phase IV requirements will be reviewed.

Executive Summary

INTERNEURON REDUX PHASE IV ADVISORY COMMITTEE REVIEW expected for Nov. 22 to address issues for post-marketing studies of the weight loss agent. Redux (dexfenfluramine) was approved on April 29 for weight loss management in the treatment of obesity. The original approval included requirements for two types of post-approval studies: "a clinical pharmacokinetic fast/fed study" and a "clinical neuropsychological function study." Wyeth-Ayerst has said that the drug is generating "an average rate of 65,000 new prescriptions each week."
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