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Self-Selection Doubts Are No Friend To Alli As Xenical Heads For Switch Panel

This article was originally published in The Tan Sheet

Executive Summary

FDA has cited a number of unresolved consumer safety concerns in GlaxoSmithKline's Rx-to-OTC switch application for weight-loss drug Alli (Xenical/orlistat 60 mg) stemming from self-selection issues observed in the drug's actual use study
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Alli Makes Passing Grade On Safety; Advisory Committee Debates Benefit
Future Alli Actual Use, Label Comprehension Commitments Likely

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