FDA REJECTS SANOFI-AVENTIS DRUG APPLICATION

The FDA has issued a not approvable letter for sanofi-aventis' dronedarone, but the company vows to continue pursuing the product.

Sanofi-aventis also announced the U.S. District Court for the Central District of California has moved the patent trial date for its blood thinner Lovenox to Dec. 4.

Dronedarone is being developed by sanofi-aventis to treat atrial fibrillation and atrial flutter. The company said it intends to resubmit its application in the first part of 2008 after completion of a new trial. The study, which has been expanded to include 4,300 patients, is intended to determine dronedarone's effectiveness and tolerability in those with atrial fibrillation.

This is not the first setback for dronedarone. Three years ago the company, then called Sanofi-Synthelabo, stopped a trial of the drug in patients with congestive heart failure and ventricular dysfunction.