Solvay files Pulzium IV with US FDA

Belgian drugmaker Solvay says that its dossier for Pulzium IV (intravenous tedisamil), a New Chemical Entity developed in-house, has been filed for approval with the US Food and Drug Administration, as well as with the authorities of European Union member states. The regulatory submission is based on safety and efficacy studies that evaluated Pulzium IV for the rapid conversion of recent-onset atrial fibrillation or atrial flutter to normal sinus rhythm in more than 1,000 symptomatic AF patients. The agent is a class III anti-arrhythmic drug which blocks multiple potassium channels.