ZimultiTreatment for Obesity
Rimonabant Update in the United States
PARIS, December 8, 2006 -- Sanofi-aventis announces that concerning the New Drug Application for rimonabant in the United States, the Food and Drug Administration has considered its October 26, 2006 resubmission to be a complete, class 2 response to the FDA February 17, 2006 action letter.
The user fee goal date is April 26, 2007.
Rimonabant is a first-in-class cannabinoid type 1 (CB1) receptor blocker discovered and developed by sanofi-aventis.
In Europe, rimonabant, known as Acomplia is approved as an adjunct to diet and exercise for the treatment of obese patients (BMI greater than or equal to 30kg/m2), or overweight patients (BMI>27kg/m2) with associated risk factors, such as type 2 diabetes or dyslipidaemia.
Rimonabant is currently commercialized in the United Kingdom, Germany, Denmark, Sweden, Finland, Norway, Ireland, Argentina and Austria.
Posted: December 2006
- Sanofi-aventis to Discontinue all Clinical Trials with rimonabant - November 6, 2008
- Rimonabant - Regulatory Update in Europe - November 14, 2007
- Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Acomplia/Zimulti - July 19, 2007
- Rimonabant Regulatory Update in the United States - June 29, 2007
- Weight Loss Drug Rimonabant Can Cause Serious Physical and Psychological Harm and Birth Defects, Public Citizen Tells FDA - June 14, 2007
- FDA Advisory Committee Did Not Recommend Approval of Rimonabant (Zimulti) for Use in Obese and Overweight Patients With Associated Risks Factors - June 13, 2007
- Rimonabant USA: Update - Mar 26, 2007 - March 26, 2007
- Sanofi-aventis Acknowledges FDA Announcement of an Advisory Committee Meeting for rimonabant - March 26, 2007
- Rimonabant USA: Update - Feb 12, 2007 - February 12, 2007
- Sanofi-aventis Received from the FDA an Approvable Letter for Rimonabant for Weight Management and a Non Approvable Letter for Smoking Cessation - February 17, 2006
- Rimonabant Accepted for Filing By the FDA - June 23, 2005