Sanofi-Aventis Pulls Drug Application | Chemical & Engineering News
Volume 85 Issue 28 | p. 22 | Concentrates
Issue Date: July 9, 2007

Sanofi-Aventis Pulls Drug Application

Department: Business | Collection: Economy

Sanofi-Aventis has withdrawn its application for FDA approval of its antiobesity drug rimonabant.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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