NRT Delivery Innovation Proposal In US Doesn't Deliver Expanded Indications

 
• By Malcolm Spicer

GSK's proposed usage for mouth spray product – reducing withdrawal symptoms, including nicotine craving – differs little from the first NRT product approved in US in 1984. Additional suggested label instructions primarily focus on stating NRTs can be used to reduce smoking or gradually stop tobacco use as opposed to quitting within a specified amount of time.

Nicorette line
GSK seeks FDA approval for a mouth spray NRT to add to the Nicorette gum, lozenge and patch products it already markets OTC in the US.

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