ZimultiAcompliaReport
Your INDEPENDENT source of news about diet drug Acomplia / Zimulti (Rimonabant)  
Zimulti Acomplia News -- June 2007 -- News About Rimonabant
 

Sanofi Withdraws Bid to Sell Diet Drug Acomplia (Rimonabant) in United States

 

The effort to get diet drug rimonabant (Acomplia / Zimulti) approved for sale in the United States temporarily ended on June 29th, when Sanofi-Aventis withdrew its application rather than await next month's near-certain rejection by the U.S. Food and Drug Administration.

The action followed the crushing vote two weeks ago of the FDA's expert advisory committee, which unanimously recommended that sale of rimonabant not be permitted in the United States pending further study of rimonabant's link to an increased risk of depression and suicidality.

Sanofi, in a statement, said it would "undertake the necessary discussions with the FDA to determine" what additional data is needed before resubmitting its application, which will likely not occur until 2010.

But, the company added, "Sanofi-Aventis is committed to making all efforts necessary to make rimonabant available to patients in the U.S. market."

Rimonabant, the first weight-loss drug which works by blocking CB-1 receptors in the brain, has been on sale in Europe for more than a year and currently is approved for sale in 42 countries.

European Union regulators said a week ago following the FDA advisory panel decision that they will review the medicine for psychiatric side effects, and said today they are "currently reviewing the available data on psychiatric events (in particular suicidal ideation and depression-related events).

"The review is expected to be finalised at the July meeting and its outcome will be communicated then," the European Medicines Agency added.

 
 
 
 
 
Privacy Policy | Terms and Disclaimers | About the Acomplia Report
Click to VerifyWe subscribe to the HONcode principles of the HON Foundation.

This is an independent news site reporting on rimonabant, a diet drug developed by Sanofi-Synthelabo Inc., which plans to market it under the trademarked name Acomplia. Nothing on this site is intended to infringe on that trademark. Nothing on this site is intended as medical advice. The information provided here is for informational purposes only. Always consult a doctor or medical professional with questions you may have regarding a medical condition.

(c) 2004-2006 Medical Week News, Inc. All Rights Reserved

Last Updated: 06/29/2007