Thursday, April 26, 2007
atrium fibrillatie
Treatment for Atrial Fibrillation and Flutter
Solvay Pharmaceuticals Files Tedisamil, a New Cardiometabolic Product for the Treatment of Atrial Fibrillation and Atrial Flutter
BRUSSELS, Belguim, April 25, 2007--Solvay announced today that its dossier for intravenous tedisamil (intended brand name: Pulzium IV), a new chemical entity coming from Solvay Pharmaceuticals R&D laboratories, has been filed for approval by the US Food and Drug Administration (FDA) as well as by the authorities of European Union countries. This means that the formal processing and review have begun.
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 1000 patients with symptomatic atrial fibrillation or flutter. Pulzium IV is a class III anti-arrhythmic drug which blocks multiple potassium channels.
“We believe that Pulzium IV represents a valuable treatment option for cardiologists treating patients with recent onset atrial fibrillation or flutter. Used as a 30 minute intravenous infusion, it converts atrial flutter or fibrillation back to sinus rhythm and becomes a worthwhile addition to the other cardiometabolic treatments we offer”, said Claus Steinborn, Executive Vice President R&D of Solvay Pharmaceuticals.
Solvay Pharmaceuticals Files Tedisamil, a New Cardiometabolic Product for the Treatment of Atrial Fibrillation and Atrial Flutter
BRUSSELS, Belguim, April 25, 2007--Solvay announced today that its dossier for intravenous tedisamil (intended brand name: Pulzium IV), a new chemical entity coming from Solvay Pharmaceuticals R&D laboratories, has been filed for approval by the US Food and Drug Administration (FDA) as well as by the authorities of European Union countries. This means that the formal processing and review have begun.
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 1000 patients with symptomatic atrial fibrillation or flutter. Pulzium IV is a class III anti-arrhythmic drug which blocks multiple potassium channels.
“We believe that Pulzium IV represents a valuable treatment option for cardiologists treating patients with recent onset atrial fibrillation or flutter. Used as a 30 minute intravenous infusion, it converts atrial flutter or fibrillation back to sinus rhythm and becomes a worthwhile addition to the other cardiometabolic treatments we offer”, said Claus Steinborn, Executive Vice President R&D of Solvay Pharmaceuticals.
# posted by roodbont @ 1:22 AM 
