Berlex Betapace
Executive Summary
FDA's Cardio-Renal Drugs Advisory Committee will review the class III anti-arrhythmic agent sotalol (NDA 19-865) for prevention of the recurrence of chronic or paroxysmal atrial fibrillation or flutter on April 29 beginning at 9 a.m. Betapace is approved for documented ventricular arrhythmia. The committee will meet to discuss anti-arrhythmia trials in patients with implanted ventricular defibrillators on April 30 starting at 8:30 a.m. The meeting will be held at the National Institutes of Health Masur Auditorium in Bethesda, Md