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In Brief: Nicorette exclusivity

This article was originally published in The Tan Sheet

Executive Summary

Nicorette exclusivity: Washington, D.C. law firm McKenna & Cuneo petitions FDA on Feb. 16 for stay of action regarding the issuance of three-year market exclusivity for SmithKline Beecham's recently approved smoking cessation gum until the agency responds to a Nov. 2 citizen petition from the same firm. The earlier petition, filed on behalf of an unnamed "pharmaceutical" client, argues that Nicorette should not be granted exclusivity because it does not represent a "significant innovation" and the switch is not based on clinical trials ("The Tan Sheet" Nov. 20, 1995, p.2)...

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