GSK’s Proposal For Mouth Spray Nicorette Delayed By FDA Questions On Label
Glaxo plans to make changes FDA requested in Complete Response letter sent on 18 October, the agency’s deadline for acting on NDA for an oral spray that delivers 1 mg per spray of aqueous buffered nicotine solution for oromucosal use.
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JAMA study results could spur additional research with subjects from broader pool of candidates for determining whether ENDS products have potential for approval as NRT products. Studies typically limit participants to consumers who want to quit, but expanding pool to include those not interested could add to research results more instances of successful quitting.
Kanabo, with headquarters in London and R&D in Tel Aviv, says its CBD and nicotine formula has advanced in the patent process from being recognized in the UK to being considered for recognition in the US and the EU, a step it calls “the last phase before becoming an internationally approved patent.”
Warnings to five marketers don’t state smoking cessation claims and vaping also aren’t related. Rather providing nicotine replacement therapy, the products identified in the warnings were reported as being marketed with claims including “Fight off tumors and alleviate symptoms of chemotherapy."