Executive Summary

NDAC September meetings: FDA formally announces the Sept. 27-28 joint meetings of the Nonprescription Drugs Advisory Committee in the Aug. 22 Federal Register. On Sept. 27, NDAC and the Endocrinologic & Metabolic Drugs Advisory Committee will review Bristol-Myers Squibb's switch NDAs for Questran and Questran Light and discuss issues related to cholesterol-reducing treatments. On Sept. 28, NDAC meets with the Drug Abuse Advisory Committee to discuss SmithKline Beecham's Nicorette (2 mg and 4 mg) and with the Gastrointestinal Drugs Advisory Committee to review Whitehall-Robins' NDA for nizatidine 75 mg ("The Tan Sheet" Aug. 21, pp 1-4). Both meetings begin at 8:30 a.m. in Conference Rooms D & E of FDA's Parklawn Building. On Sept. 29, NDAC will attend a public hearing on OTC labeling reform. A closed session is scheduled for 5-6 p.m. on Sept. 27 with the endocrine committee...