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Nonprescription Drugs Advisory Committee

The committee discussed a new drug application (NDA) by GlaxoSmithKline Consumer Healthcare Holdings for over-the-counter (OTC) nicotine mouth spray (NMS). A narrow majority of the committee, eight of fifteen committee members, voted that the data submitted in the NDA provide substantial evidence of efficacy of NMS as a smoking cessation aid in the OTC setting. A majority of the committee, nine of fifteen committee members, voted that the data provide substantial evidence of safety of OTC use of NMS. A majority of the committee, nine of fifteen committee members, voted that the risk/benefit profile of NMS is supportive of OTC use of NMS as a smoking cessation aid.