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In Brief: NDAC meetings

This article was originally published in The Tan Sheet

Executive Summary

NDAC meetings: Joint meeting of FDA's Nonprescription Drugs and Gastrointestinal Drugs Advisory Committee to discuss Glaxo's NDA for the Rx-to-OTC switch of Zantac 75 for the treatment of heartburn set to begin at 8:30 a.m. on June 13, the agency announces in a June 21 Federal Register notice. On July 14, NDAC and the Arthritis Advisory Committee will meet jointly beginning at 8:30 a.m. to discuss NDAs filed by Bayer and Whitehall-Robins covering the switch of ketoprofen 12.5 mg for relief of minor pain associated with colds, toothaches, muscular aches, arthritis, menstural cramps and reduction of fever ("The Tan Sheet" June 12, p. 1). The July 14 schedule includes a closed session from 12-1 p.m. The meetings will be held in conference rooms D and E of FDA's Parklawn Building in Rockville, MD...
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