Smoking cessation drug labeling
This article was originally published in The Tan Sheet
Executive Summary
Packaging for GSK's Nicorette gum and NicoDerm CQ transdermal patch will be modified to reflect FDA-mandated pregnancy/breastfeeding warning, which reads in part: "If you are pregnant or breastfeeding, only use this medicine on the advice of your healthcare provider." Supplemental NDAs for Nicorette (NDA 18-612/S-031, NDA 20-066/S-13) and NicoDerm CQ (NDA 20-165/S-020) were approved separately Aug. 9 and 13, respectively...