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Nonprescription Drugs Advisory Committee to review Nicorette, Axid OTC switches Sept. 28.

Executive Summary

NICORETTE AND AXID OTC SWITCH APPLICATIONS WILL BE REVIEWED by FDA's Nonprescription Drugs Advisory Committee Sept. 28. In the morning and early afternoon, NDAC and the Drug Abuse Advisory Committee will discuss SmithKline Beecham's Rx-to-OTC switch of the nicotine chewing gum Nicorette 2 mg and 4 mg (NDAs 20-066 and 18-612). Later in the afternoon, NDAC and members of FDA's Gastrointestinal Drugs Advisory Committee will discuss data relevant to Whitehall-Robins' switch NDA (20-555) for Axid (nizatidine) tablets 75 mg. The meeting begins at 8:30 a.m. at FDA's Parklawn building, Conference Rooms D&E.

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