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Bayer, Whitehall NDAs for ketoprofen switch; OTC Zantac on July 13-14 NDAC agenda.

This article was originally published in The Tan Sheet

Executive Summary

BAYER, WHITEHALL-ROBINS' KETOPROFEN Rx-TO-OTC SWITCHES SET FOR NDAC REVIEW at a July 14 joint meeting with FDA's Arthritis Advisory Committee. Bayer Consumer Care and American Home Products subsidiary Whitehall-Robins filed separate NDAs in support of ketoprofen 12.5 mg for the over-the-counter treatment of pain and fever. The joint meeting of the Nonprescription Drugs and Arthritis Advisory Committees begins 8:30 a.m. in conference rooms D&E of FDA's Parklawn Building in Rockville, Md.

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