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Consumer OTC Drugs

SmithKline Beecham to conduct Phase IV Nicotrol safety/efficacy study in adolescents.

This article was originally published in The Tan Sheet

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  • The Tan Sheet

Executive Summary

NICOTROL PATCH PHASE IV COMMITMENTS INCLUDE SURVEILLANCE OF SALES TO MINORS and a study of the safety and efficacy of Nicotrol use in adolescents, FDA reminded McNeil in its recent approval letter for the Rx-to-OTC switch nicotine patch therapy. The requirements are nearly identical to those for the other smoking cessation aid recently switched to OTC status -- SmithKline Beecham's Nicorette nicotine replacement chewing gum ("The Tan Sheet" Feb. 19, p. 5).

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