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Habitrol

This article was originally published in The Tan Sheet

Executive Summary

CHPA urges FDA to grant marketing exclusivity to Novartis Consumer Health for transdermal nicotine patch. In comments submitted to agency Dec. 7, CHPA says "it is vital for FDA to maintain a regulatory environment conducive to the appropriate switch of drugs from prescription to OTC use." Trade group reiterates Novartis' claim that shortened duration of use and new, essential clinical investigation entitles company to three-year marketing exclusivity (1"The Tan Sheet" Nov. 6, p. 11). FDA is reviewing its initial exclusivity denial
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