Zimulti
Generic name: rimonabant
Treatment for: Weight Loss (Obesity/Overweight)
Sanofi-aventis to Discontinue all Clinical Trials with rimonabant
Sanofi-aventis to Discontinue all Clinical Trials with rimonabant
Paris, November 5, 2008 - Sanofi-aventis announced today that it has decided to discontinue the ongoing rimonabant clinical development program in all indications.
Today’s company decision has been taken in light of recent demands by certain national health authorities. As a result the feasibility of the global clinical development program has been compromised.
Sanofi-aventis will inform Health Care Professionals as of today. Persons currently enrolled in these clinical trials should consult their clinical investigator to discuss their treatment.
This announcement does not change the Company’s guidance for 2008.
About sanofi-aventis Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, please visit: www.sanofi-aventis.com.
Forward Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2007. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Posted: November 2008
Related articles
- 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 andPsychological 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
- 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
Zimulti (rimonabant) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.