Sanofi-Aventis says that the FDA has rejected its heart drug Multaq (dronedarone), evidently unsatisfied with the data provided to support its application. Multaq is designed to treat atrial fibrillation. Sanofi-Aventis hasn't given up on the drug, though. The company says it plans to refile for approval in the first half of 2008, after it receives a fresh batch of data from an ongoing study. Last February the FDA rejected Sanofi-Aventis' bid to market Acomplia. And analysts weren't happy to see the European drug maker rejected again as it hurries to shore up its revenue in the face of new generic competition for Lovenox and Plavix.
- here's the International Herald Tribune's report [1] on Multaq
PLUS: Sanofi-Aventis announced that the trial to decide on its continued exclusive control of Lovenox has been postponed to early December. Report [2]
Links:
[1] http://www.iht.com/articles/ap/2006/08/31/business/EU_FIN_France_Sanofi_Aventise.php
[2] http://today.reuters.com/news/articleinvesting.aspx?type=governmentFilingsNews&storyID=2006-08-31T171134Z_01_L31905873_RTRIDST_0_HEALTH-SANOFI-LOVENOX-UPDATE-1.XML