Dronedarone Slashes Hospital Days in Atrial Fib

The Food and Drug Administration in August 2006 turned down a request for approval that had relied on two previous trials using a combined end point of all-cause hospitalizations or deaths. In August 2008, the company resubmitted its application for marketing approval based on the ATHENA results and has been granted a priority review; a decision from the FDA is expected in early 2009. Dronedarone is also under regulatory review by the European Medicines Agency.

ELSEVIER GLOBAL MEDICAL NEWS