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Bristol seeking FDA meeting on Excedrin Migraine following warning letter.

This article was originally published in The Tan Sheet

Executive Summary

EXCEDRIN AD PROMOTES EXTRA STRENGTH PRODUCT FOR MIGRAINE, FDA says in a warning letter to Bristol-Myers Squibb May 8. The agency objects to advertising for Excedrin Migraine it says emphasizes the OTC analgesic is essentially the same as Excedrin Extra Strength except for different labeling, which FDA believes will lead consumers to use the extra strength product for migraine, an unapproved indication. Excedrin Migraine was approved in January for temporary relief of mild to moderate pain associated with migraine headache ("The Tan Sheet" Jan. 19, pp. 1-5). Both products contain the same aspirin/acetaminophen/caffeine formula.

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