Issue Date: July 9, 2007
Sanofi-Aventis Pulls Drug Application
Sanofi-Aventis has withdrawn its application for FDA approval of its antiobesity drug rimonabant. It is the first in a new class of drugs that selectively block receptors in the body's endocannabinoid system. In mid-June, an FDA advisory panel did not recommend approval after raising questions about psychiatric side effects. The decision casts doubt on rimonabant's potential blockbuster status, but Sanofi-Aventis says it is confident of the drug's positive benefit-risk ratio and is working to address FDA's questions and reapply for approval. Already sold in 20 countries as Acomplia, the drug was to be called Zimulti in the U.S. European regulators are reviewing its safety as well and will release their findings in a week.
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