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Consumer OTC Drugs

Nicorette actual-use studies support Waxman/Hatch exclusivity, SmithKline counsel argues..

This article was originally published in The Tan Sheet

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Executive Summary

ACTUAL-USE STUDIES SUPPORT WAXMAN/HATCH EXCLUSIVITY, NICORETTE SPONSORS SmithKline Beecham and Hoechst Marion Roussel argue in a recent letter filed by the law firm Kleinfeld, Kaplan and Becker on behalf of the two companies. The letter points out that FDA representatives directed SmithKline and Marion Merrell Dow in 1993 to conduct two large scale actual-use studies to support the Rx-to-OTC switch of the nicotine gum smoking cessation aid.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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