FDA Approves Allegra(R) (fexofenadine Hydrochloride) Oral Suspension For Treatment Of Seasonal Allergy Symptoms And Chronic Idiopathic Urticaria
Sanofi-aventis   U.S. (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and  Drug Administration (FDA) has approved Allegra(R) (fexofenadine  hydrochloride) Oral Suspension for the twice-daily treatment of symptoms  associated with seasonal allergies in pediatric patients, 2 to 11 years of  age, and for the treatment of chronic idiopathic urticaria in children 6  months to 11 years of age. This approval makes available a safe and  effective seasonal allergy treatment option that is non-impairing to  pediatric populations as young as 2 years old.
        "Until now, parents had few seasonal antihistamine treatment options  that were not associated with cognitively impairing adverse side effects,"  says Eli Meltzer, M.D., of the Allergy and Asthma Medical Group and  Research Center in San Diego. "However, with Allegra Oral Suspension, which  does not cause sedation at any dose and is well-established for its  antihistamine activity, a medication is now available in a good tasting,  easy-to-swallow formulation that can help reduce the seasonal allergy  symptoms of children."
        Seasonal allergic rhinitis is a common chronic condition in children.  Symptoms of seasonal allergies include nasal drainage, sneezing, watery  eyes and itchy nose, eyes and throat. Studies indicate that seasonal  allergy inflammation as well as the impairing side effects of older  antihistamines can be disruptive to a child and may affect cognitive skills  and function.
        Allegra Oral Suspension has also been approved for the treatment of  chronic idiopathic urticaria (CIU) in twice-daily 30 mg doses for pediatric  patients 2 to 11 years of age and twice-daily 15 mg doses for pediatric  patients 6 months to 2 years of age. CIU is a rare and bothersome condition  characterized by hives lasting more than 6 weeks from an unknown cause. Its  symptoms are caused by a reaction to an unknown trigger in the upper layers  of the skin. The condition itself may cause severe itching, but is made  worse by scratching.
         Allegra Oral Suspension will have a berry flavor* and is expected to be  available to consumers in time for the 2007 spring allergy season.
   Artificial raspberry-cream flavoring
       Important Safety Information
        Side effects in children 6 months to 5 years old were similar to  placebo. Side effects varied by age. The most commonly reported side  effects were: vomiting, pyrexia, cough, otitis media and diarrhea.
         Please see full prescribing information for Allegra Oral Suspension at  http://products.sanofi-aventis.us/allegra_oral/allegra.pdf.
         About sanofi-aventis
         Sanofi-aventis is the world's third largest pharmaceutical company,  ranking number one 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 diseases, central  nervous system, internal medicine, and vaccines. Sanofi-aventis is listed  in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)
        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 events, 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, 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, 2005. Other than as required by applicable law, sanofi- aventis does  not undertake any obligation to update or revise any forward- looking  information or statements.
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