BRISTOL-MYERS SQUIBB QUESTRAN "ACTUAL USE" STUDIES NEEDED TO SUPPORT Rx-TO-OTC SWITCH, FDA CMTE. FINDS; CURRENT DATA DO NOT SUPPORT SWITCH PETITION
Executive Summary
Actual use studies of Bristol-Myers Squibb's Questran are needed to provide data that could support an Rx-to-OTC switch for the cholesterol-lowering resin cholestyramine, members of FDA's Nonprescription Drugs and Endocrinologic & Metabolic Drugs Advisory Committees suggested at a Sept. 27 meeting in Rockville, Md.