INTERNEURON DEXFENFLURAMINE ADVISORY CMTE. REVIEW HIGHLIGHTS IMPORTANCE OF CO-MORBIDITY DATA; TWO-YEAR LARGE SIMPLE PHASE IV TRIAL SUGGESTED BY FDA
Executive Summary
FDA's Endocrinologic & Metabolic Drugs Advisory Committee's first review of a long-term obesity therapy could illustrate some of the issues facing obesity drug approval remaining after the committee's two earlier meetings addressing obesity drug development guidelines. The committee reviewed Interneuron's dexfenfluramine on Sept. 28.