Zimulti Approval Status
FDA Approved: No
Brand name: Zimulti
Generic name: rimonabant
Previous Name: Acomplia
Treatment for: Obesity
Zimulti (rimonabant) is a cannabinoid-1 receptor blocker (CB1) intended for use in the treatment of obesity, smoking cessation, and related conditions.Sanofi-Aventis has withdrawn rimonabant from the market globally and it is no longer in development. In June 2007, the FDA's Endocrine and Metabolic Drugs Advisory Committee recommended against the approval of rimonabant (known in the United States as Zimulti) due to concerns over dangerous psychological side effects, including suicidality and depression. Subsequently, the FDA did not approve rimonabant, and it has never been marketed in the United States. Acomplia, the brand name of rimonabant in Europe, was officially withdrawn by the European Medicines Agency (EMEA) in January 2009 due to the risks of these side effects. Previously, the EMEA had suspended Acomplia from the UK market in 2008 because the agency felt the benefits did not outweigh the risks.
Development Status and FDA Approval Process for Zimulti
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