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OTC nicotine patch trials fall short of Waxman/Hatch requirements -- petition.

This article was originally published in The Tan Sheet

Executive Summary

OTC HABITROL WAXMAN/HATCH MARKET EXCLUSIVITY CHALLENGED in a Feb. 24 citizen petition submitted on behalf of an unnamed client by D.C. attorney Jur Strobos, MD (Greenberg Traurig Hoffman Lipoff Rosen & Quentel). The petition requests that FDA deny three years of marketing exclusivity to OTC Habitrol, if approved, and maintains, more broadly, that the agency should not allow three years of marketing exclusivity for any OTC nicotine patch because clinical trials on such products do not meet the statutory requirements for exclusivity.

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