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Excedrin separate label for OTC migraine use may be needed -- cmte. members.

This article was originally published in The Tan Sheet

Executive Summary

EXCEDRIN EXTRA STRENGTH SEPARATE OTC LABELING FOR MIGRAINE may be necessary to accommodate the differences between a migraine indication and the current OTC monograph claims for the analgesic, FDA advisory committee members suggested at a July 15 meeting in Bethesda, Md. Summarizing committee discussions, FDA Office of Drug Evaluation V Director Michael Weintraub, MD, observed: "I think what we heard is that there needs to be a separate label for this indication....We'll have to deal with the company on this one."
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