FDA grants priority review for Sanofi a-fib drug
The FDA has assigned priority review status for Sanofi-Aventis’ new drug application (NDA) for Multaq, an atrial fibrillation drug.
The priority review period, which began July 31, is granted to applications in which a new indication or new drug product, if approved, has the potential to present a safe and effective therapy where no satisfactory alternative exists compared to currently available therapies or marketed products, according to Bridgewater, N.J.-based company.
A registration dossier is also under regulatory review by the European Medicines Agency for a marketing authorization application.
Multaq (dronedarone), a multi-channel blocker, is an investigational new treatment for patients with atrial fibrillation, which has been developed by Sanofi-aventis for the prevention and treatment of atrial fibrillation or atrial flutter.
The priority review period, which began July 31, is granted to applications in which a new indication or new drug product, if approved, has the potential to present a safe and effective therapy where no satisfactory alternative exists compared to currently available therapies or marketed products, according to Bridgewater, N.J.-based company.
A registration dossier is also under regulatory review by the European Medicines Agency for a marketing authorization application.
Multaq (dronedarone), a multi-channel blocker, is an investigational new treatment for patients with atrial fibrillation, which has been developed by Sanofi-aventis for the prevention and treatment of atrial fibrillation or atrial flutter.