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Nicotine patch labeling review should include OTCs, SmithKline tells FDA.

This article was originally published in The Tan Sheet

Executive Summary

NICOTINE PATCH LABELING REVIEW SHOULD INCLUDE OTCs, SMITHKLINE urges in May 9 comments to FDA. The agency's Drug Abuse Advisory Committee plans to meet June 9 to discuss revising nicotine patch labeling, primarily for Rx products. "While we commend the committee for its efforts in seeking to improve the labeling for smoking cessation products," SmithKline Beecham states, "we would like to remind the committee that this category is now represented not only by prescription products, but by equally efficacious OTC products."
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