Nicorette OTC use studies meet Waxman/Hatch exclusivity requirements, FDA says.
This article was originally published in The Tan Sheet
Executive Summary
NICORETTE OTC USE STUDIES JUSTIFY WAXMAN/HATCH EXCLUSIVITY for the Rx-to-OTC switch nicotine chewing gum, FDA Center for Drug Evaluation and Research Director Janet Woodcock, MD, says in an Oct. 31 letter to McKenna & Cuneo attorney Gary Yingling. Woodcock's letter responds to a Nov. 2, 1995 petition filed by McKenna & Cuneo asking FDA to deny exclusivity for the OTC smoking cessation gum product ("The Tan Sheet" Nov. 20, 1995, p. 2) and a subsequent petition for stay of action, filed February 16. The petitions were filed on behalf of an undisclosed client.