Zimulti FDA Approval Status

FDA Approved: No
Brand name: Zimulti
Generic name: rimonabant
Previous Name: Acomplia
Company: Sanofi-aventis
Treatment for: Weight Loss (Obesity/Overweight)

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Sanofi-Aventis has withdrawn rimonabant from the market globally and it is no longer in development.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 Acomplia, the brand name of rimonabant in Europe, was officially withdrawn by the European Medicines Agency (EMEA) in January 2009 due to the risks of these side effects.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 timeline for Zimulti

Date	Article
Nov  6, 2008	Sanofi-aventis to Discontinue all Clinical Trials with rimonabant
Nov 14, 2007	Rimonabant - Regulatory Update in Europe
Jul 19, 2007	Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Acomplia/Zimulti
Jun 29, 2007	Rimonabant Regulatory Update in the United States
Jun 14, 2007	Weight Loss Drug Rimonabant Can Cause Serious Physical andPsychological Harm and Birth Defects, Public Citizen Tells FDA
Jun 13, 2007	FDA Advisory Committee Did Not Recommend Approval of Rimonabant (Zimulti) for Use in Obese and Overweight Patients With Associated Risks Factors
Mar 26, 2007	Rimonabant USA: Update - Mar 26, 2007
Mar 26, 2007	Sanofi-aventis Acknowledges FDA Announcement of an Advisory Committee Meeting for rimonabant
Feb 12, 2007	Rimonabant USA: Update - Feb 12, 2007
Dec  8, 2006	Rimonabant Update in the United States
Feb 17, 2006	Sanofi-aventis Received from the FDA an Approvable Letter for Rimonabant for Weight Management and a Non Approvable Letter for Smoking Cessation
Jun 23, 2005	Rimonabant Accepted for Filing By the FDA

Further information

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