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Bayer, Whitehall ketoprofen NDAs include 19 clinical trials presented to advisory cmte..

This article was originally published in The Tan Sheet

Executive Summary

BAYER, WHITEHALL KETOPROFEN SUBMISSIONS INCLUDE 19 CLINICAL STUDIES that were presented at the July 14 meeting of FDA's Nonprescription Drugs and Arthritis Advisory Committees. Bayer's NDA for the Rx-to-OTC switch of ketoprofen included 10 studies, while Whitehall-Robins outlined data from nine of the studies submitted with its application. The data formed the basis for the committees' recommendation that ketoprofen 12.5 mg be approved as an OTC analgesic ("The Tan Sheet" July 17, p. 1).

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