FDA panel rejects Sanofi-Aventis weight loss drug

Share this article:

An FDA advisory panel today unanimously rejected approval of Sanofi-Aventis' weight-loss drug rimonabant after hearing testimony that the drug increases the risk of suicidal behavior.

The panel's finding makes it unlikely that the FDA will grant approval for the drug. The agency usually follows the advice of its advisory panels, although it is not required to do so.

The FDA is scheduled to make a final decision on rimonabant by July 27.

The company proposes selling the drug under the brand name Zimulti. Rimonabant is already sold in Europe as Acomplia.

Share this article:

Email Newsletters

More in News

Five things for Pharma Marketers to know: Wednesday, August 27

Five things for Pharma Marketers to know: Wednesday, ...

Allergan sets a shareholder voting date, Novo describes the types of acquisitions it will consider, and the AstraZeneca-Pfizer talks can now reopen.

Eli Lilly and BI's Jardiance hits shelves

Eli Lilly and BI's Jardiance hits shelves

The new SGLT-2 inhibitor is on shelves less than a month after FDA approval.

PhRMA Urges Court to Reject Off-Label Promotion Case

PhRMA Urges Court to Reject Off-Label Promotion Case

The Pharmaceutical Research and Manufacturers of America (PhRMA) says a California federal court should dismiss a whistleblower's False Claims Act suit against three drug companies on First Amendment grounds