PARIS, April 11 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for AMBIEN CR(TM) (zolpidem tartrate extended release) CIV. AMBIEN CR(TM) is the controlled-release formulation of zolpidem, the world's leading sleep aid(1).
An approvable letter outlines specific questions that have to be resolved before the Agency will approve a product for marketing.
Sanofi-aventis Group is already working closely with the FDA to address the questions outlined in the letter. The FDA's questions relate specifically to AMBIEN CR(TM) and are not related to the safety and efficacy of AMBIEN(R) (zolpidem tartrate).
AMBIEN(R) is indicated for the short-term treatment of insomnia. There is a low occurrence of side effects associated with the short-term use of AMBIEN(R). The most commonly observed side effects in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%). When you first start taking AMBIEN(R), use caution in the morning when engaging in activities requiring complete alertness until you know how you will react to this medication. In most instances, memory problems can be avoided if you take AMBIEN(R) only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again. As with any sleep medication, do not use alcohol while you are taking AMBIEN(R). Prescription sleep aids are often taken for 7 to 10 days-or longer as advised by your doctor. All people taking sleep medicines have some risk of becoming dependent on the medicine.
For full prescribing information, please visit http://www.ambien.com/
Sanofi-aventis Group is the world's 3rd largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, sanofi- aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic disorders, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
The sanofi-aventis Group conducts business in the U.S. through its affiliates Sanofi-Synthelabo Inc. and Aventis Pharmaceuticals Inc.
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "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 those discussed or identified in the public filings with the SEC and the AMF made by Sanofi-aventis and Aventis, including those listed under "Forward-Looking Statements" and "Risk Factors" in sanofi-aventis's annual report on Form 20-F for the year ended December 31, 2003 and those listed under "Cautionary Statement Regarding Forward-Looking Statements" and "Risk Factors" in Aventis's annual report on Form 20-F for the year ended December 31, 2003. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
U.S. Contact: Melissa Feltmann, 908-243-7080, melissa.feltmann@sanofi- aventis.com