Executive Summary

NICORETTE EXCLUSIVITY DECISION "STAY OF ACTION" NOT WARRANTED, FDA concludes in an Oct. 31 letter from Center for Drug Evaluation & Research Director Janet Woodcock, MD, to McKenna & Cuneo attorney Gary Yingling. The D.C. law firm, representing an unnamed client, requested in a Feb. 16 citizen petition that if relief sought in its November 1995 petition requesting denial of exclusivity for the OTC smoking cessation chewing gum were turned down, FDA Commissioner David Kessler should "stay issuance of market exclusivity to Nicorette until the completion of judicial review of the agency's decision." FDA says it "does not agree that a stay of action is warranted."