Bristol-Myers Squibb data supporting Questran switch found lacking by FDA committee.
This article was originally published in The Tan Sheet
Executive Summary
BRISTOL-MYERS' QUESTRAN Rx-TO-OTC SWITCH DATA FOUND INSUFFICIENT to support the over-the-counter availability of the product by FDA's Nonprescription Drugs and Endocrinologic & Metabolic Drugs Advisory Committees at a joint meeting on Sept. 27. Bristol-Myers Squibb is seeking FDA approval to market Questran (cholestyramine) and Questran Light as OTC treatments for hypercholesterolemia.