Berlex Betapace Indication Should Specify Normal Sinus Rhythm - Cmte.
Executive Summary
Berlex' Betapace indication for atrial fibrillation patients should include language emphasizing the anti-arrhythmic's intended use in patients in normal sinus rhythm rather than for conversion from atrial fibrillation or flutter, FDA's Cardio-Renal Drugs Advisory Committee members told the agency April 29.