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Wednesday, September 18, 2019

FDA advisory committee narrowly backs Glaxo OTC nicotine spray

In a close 8-7 vote, the FDA’s Nonprescription Drugs Advisory Committee backed the efficacy of GlaxoSmithKline’s (GSK) over-the-counter (OTC) nicotine oral spray as a smoking cessation aid in adults who are trying to quit smoking.
Update: The committee voted 9-6 in favor of the safety profile.
Update: The committee voted 9-6 in favor of the risk/benefit profile in an OTC setting.

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