Bayer and Whitehall ketoprofen OTC switch NDAs get advisory committee okay.
This article was originally published in The Tan Sheet
Executive Summary
BAYER AND WHITEHALL KETOPROFEN Rx-TO-OTC SWITCH NDAs RECOMMENDED for approval at a joint meeting of FDA's Arthritis and Nonprescription Drugs Advisory Committees July 14 in Rockville, Md. The committees voted unanimously that ketoprofen 12.5 mg can be used safely and effectively as an over-the-counter nonsteroidal anti-inflammatory drug.