Sanofi-aventis announced it would withdraw its new drug application for Zimulti (Rimonabant) after an FDA advisory committee recommended against approving the drug over concerns it increased the risk of suicide.
The agency’s Endocrinological and Metabolic Drugs Advisory Committee voted unanimously that available safety data was insufficient to evaluate Zimulti’s (rimonabant) risk profile. The committee held the meeting over concerns of potential safety signals for psychiatric adverse events and suicidality.
Sanofi-aventis also said it plans to submit an update of rimonabant’s safety data to the European Medicine’s Agency (EMEA) Committee for Medicinal Products for Human Use. The agency announced it will review data on psychiatric events as part of its continuous monitoring of the drug’s safety. The EMEA announced it would re-examine the drug after the FDA advisory committee voted against its approval.
Source: American College of Clinical Pharmacology eNews group dated 3rd July 2007.
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