Bristol Questran OTC switch for cholesterol lowering set for advisory committee review.

Executive Summary

BRISTOL QUESTRAN OTC SWITCH APPLICATION ADVISORY COMMITTEE REVIEW by FDA's Nonprescription Drugs and Endocrinologic & Metabolic Drugs Advisory Committees is set for Sept. 27. The committees will review data from Bristol-Myers Squibb's Rx-to-OTC switch NDAs for the cholestyramine products Questran and Questran Light (NDAs 16-640 and 19-669). Both Questran and Questran Light are intended as adjunctive therapies for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low-density lipoprotein) who do not respond adequately to diet alone. Bristol's Questran NDAs are the first switch applications for cholesterol-lowering drugs to reach FDA advisory committee review.