With Novel NRT Proposal, GSK Includes Novel Labeling: 'Quick Start Guide'
Executive Summary
Results of both its clinical trials showed significantly higher rates of smoking abstinence, but GSK adds first labeling for an NRT formatted as a Quick Start Guide and makese other label changes "to further assist consumers in how to use the spray dispenser." Similarity of mouth spray formulation's safety profile to other OTC NRTs is a key point in GSK's proposal.
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