ZimultiTreatment for Obesity
Rimonabant USA: Update - Feb 12, 2007
PARIS, February 12 2007 -- Sanofi-aventis announced today that the review period of rimonabant in the United State has been extended by three months, until July 27, 2007.
The Group also announced the submission of the SERENADE clinical study report today in the rimonabant NDA submitted to the FDA.
Rimonabant is a first- in-class cannabinoid type 1 receptor discovered and developed by sanofi- aventis.
SERENADE (Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients) is a multi-centre, randomized, double-blind, placebo-controlled, parallel-group study comparing rimonabant 20 mg once daily to placebo in improving blood sugar control in treatment-naive type 2 diabetic patients not adequately controlled by diet alone for a period of six months.
Posted: February 2007
- 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 Update in the United States - December 8, 2006
- 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