Sanofi-Aventis: safety concerns delay US approval for obesity drug

August 2007
PharmaWatch: Monthly Review;Aug2007, Vol. 6 Issue 8, p10
Market Research Report
The article reports on the failure of an advisory panel of the Food and Drug Administration (FDA) to endorse rimonabant under development by Sanofi-Aventis SA because of concerns over its safety profile. Depression and other psychiatric side effects have remained the biggest concern in studies with rimonabant. In this connection, Sanofi-Aventis will have to submit additional clinical trial to prove the safety of the agent.


Related Articles

  • Sanofi axes its much-hyped NDA. McGuire, Stephen // Medical Marketing & Media;Aug2007, Vol. 42 Issue 8, p10 

    The article reports that Sanofi-Aventis SA has withdrawn its New Drug Application (NDA) for weight-loss drug rimonabant in the U.S. The company is planning to work toward its resubmission after it was disapproved by the Food and Drug Administration (FDA) for its link to suicidal behavior and...

  • Restoring Confidence in the Pharmaceutical Industry. Bauchner, Howard; Fontanarosa, Phil B. // JAMA: Journal of the American Medical Association;2/13/2013, Vol. 309 Issue 6, p607 

    The authors discuss issues related to the lack of trust in pharmaceutical industries which sponsor funds for major clinical trials for advancement in the biomedical field. The involvement of pharmaceutical industries in manipulation of results related to clinical trials for faster approval of...

  • Extended-release Ambien gains FDA nod.  // Drug Topics;9/26/2005, Vol. 149 Issue 18, p10 

    This article reports that Sanofi-Aventis SA has received U.S. Food and Drug Administration approval for its extended-release version of Ambien, or zolpidem tartrate, for the treatment of insomnia.

  • Drugmakers cited for 'misleading' ads.  // Indianapolis Business Journal;4/13/2009, Vol. 30 Issue 6, p19 

    The article reports that 14 drugmakers had been cited by the U.S. Food & Drug Administration (FDA) for using the misleading advertisements. It is reported that FDA blamed 14 drugmakers including Pfizer Inc., and Sanofi-Aventis SA for failing to identify product names and side effects linked with...

  • The FDA's new clothes. Light, Donald W.; Lexchin, Joel // BMJ: British Medical Journal;9/26/2015, Vol. 351 Issue 8026, ph4897 

    The authors reflect on whether the U.S. Food and Drug Administration is still effective in its position as the agency tasked with ensuring drug safety throughout a product's life cycle. They recall the controversy surrounding the approval of the anti-inflammatory drug Vioxx. They cite two...

  • Sanofi: Lemtrada will emerge as a key MS therapy if concerns are addressed.  // PharmaWatch: CNS;Aug2011, Vol. 10 Issue 8, p5 

    The article offers updates on the development of Lemtrada, a drug for multiple sclerosis treatment from drugmaker Sanofi-Aventis SA. It notes that the Phase III clinical study of the drug shows that the drug is more effective in reducing relapses than interferons but depicts uncertainty in...

  • REPORTERS Notebook.  // Drug Store News;4/23/2007, Vol. 29 Issue 6, p35 

    The article reports developments in the pharmaceutical industry in the U.S. Janssen's Risperdal was approved by the Food and Drug Administration (FDA) for children, giving it six months' pediatric marketing exclusivity. Ranitidine syrup oral solution USP from Actavis and Taro received approval...

  • Benefits outweigh risks in treatment of depressed youth. Sipkoff, Martin // Drug Topics;3/6/2006, Vol. 150 Issue 5, p3s 

    The article reports that the U.S. Food and Drug Administration (FDA) ordered black box warnings for antidepressants stating that the drugs may increase the risk of pediatric suicidal thinking and behavior. According to a review of psychological autopsy studies by the American College of...

  • New molecular entities.  // Formulary;Aug2009, Vol. 44 Issue 8, p223 

    The article presents information on the drugs which recently got the approval of the Food & Drug Administration (FDA) of the U.S. The drugs include Prasugrel from Lilly & Co. Ltd. and Daiichi Sankyo Co. Ltd. and Dronedarone from Sanofi-Aventis SA. It informs that Prasugrel can be used for the...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics