Nicotine patch labeling on preventing relapse suggested by McNeil.
This article was originally published in The Tan Sheet
Executive Summary
NICOTINE PATCH PREVENTING RELAPSE LABELING SUGGESTED BY McNEIL as a proposed revision of current labeling for OTC smoking cessation products. McNeil Consumer Products bases its comments on the clinical trial it submitted as part of its 1995 NDA for the Rx-to-OTC switch of the Nicotrol 15 mg nicotine patch. The comments are intended as a preview to FDA's June 9 Drug Abuse Advisory Committee meeting on revising nicotine patch labeling (mostly Rx products).