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In Brief: Nicotine patches granted exclusivity

This article was originally published in The Tan Sheet

Executive Summary

Nicotine patches granted exclusivity: FDA grants SmithKline Beecham's Nicoderm CQ and J&J/McNeil's Nicotrol nicotine replacement patches three years of Waxman/Hatch market exclusivity beginning on the dates the Rx-to-OTC switch applications were approved. Nicoderm CQ was approved by FDA Aug. 2 ("The Tan Sheet" Aug. 5, 1996, p. 1). Nicotrol was approved July 3 ("The Tan Sheet" July 8, 1996, p. 1). SmithKline's Nicorette gum received exclusivity in October 1996, retroactive to its Feb. 9, 1996 approval ("The Tan Sheet" Nov. 11, 1996, p. 1)...
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