GSK’s Proposal For Mouth Spray Nicorette Delayed By FDA Questions On Label

GlaxoSmithKline PLC’s proposal to market the first mouth spray nicotine replacement therapy available in the US has been delayed by the Food and Drug Administration questions about the OTC product’s Drug Facts label.

A GSK representative on 8 January told HBW Insight that the firm plans to make changes the FDA requested in a Complete Response letter sent on 18 October, which was the agency’s deadline for acting on the new drug application GSK Consumer Healthcare Holdings LLC submitted for an oral spray that delivers 1 mg per spray of aqueous buffered nicotine solution for oromucosal use