FDA Approves Xyzal For Use In Children Six Months And Older

FDA Approves Xyzal For Use In Children Age Six Months And Older For The Relief Of Perennial Allergic Rhinitis And Chronic Idiopathic Urticaria

ATLANTA and BRIDGEWATER, N.J., Aug. 24 /PRNewswire/ -- UCB and sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) has approved Xyzal (levocetirizine dihydrochloride) for children age six months and older for the relief of symptoms of perennial allergic rhinitis (indoor allergies) and chronic idiopathic urticaria (chronic hives) and for children age two years and older for symptoms of seasonal allergic rhinitis (outdoor allergies). Until now, Xyzal , a once-daily prescription antihistamine in both tablet and liquid formulations, has been used to treat symptoms of indoor and outdoor nasal allergies, as well as chronic idiopathic urticaria in patients age six years and older.

"There are options for treating nasal allergies in young children, one of which is Xyzal . The availability of a liquid treatment with the established safety and efficacy of Xyzal provides caregivers a new treatment option that can help relieve nasal allergy symptoms in young patients once diagnosed by a physician," said Michael Blaiss, M.D., clinical professor of pediatrics and medicine at the University of Tennessee Health Science Center; past president of the American College of Allergy, Asthma, and Immunology (ACAAI) and co-editor of the Atlas of Allergic Diseases.

Nasal allergies are currently the most common chronic condition found in children, with allergic rhinitis believed to affect as many as 40 percent of U.S. children. Recognizing the symptoms and increased hereditary risk are key elements to ensuring early diagnosis and proper management. A child with one parent living with allergies has a 48 percent chance of developing allergies, while a child with two parents living with allergies has a 70 percent chance of developing allergies.

Xyzal tablets received FDA approval on May 25, 2007 and Xyzal oral solution received FDA approval on February 19, 2008.

In September 2006, UCB and sanofi-aventis U.S. entered into an agreement to launch and co-market Xyzal in the U.S. UCB and sanofi-aventis U.S. have a long history in the nasal allergy treatment arena and are committed to advancing treatment for nasal allergy sufferers and helping meet unmet medical needs for patients with chronic nasal allergy symptoms.

About Allergic Conditions

Many people suffer from the symptoms associated with common allergic conditions. The immune system of nasal allergy sufferers overreacts to something in the environment, leading to symptoms that affect their respiratory system, eyes, or skin. Experts estimate indoor and outdoor nasal allergies affect as many as 40 million people in the U.S.

Seasonal allergic rhinitis (SAR), commonly referred to as "hay fever" or "outdoor allergies," is the most common form of allergic rhinitis. By definition, SAR includes nasal allergies to seasonal pollens like grass, trees, and weeds, as well as mold. Perennial Allergic Rhinitis (PAR) is sometimes referred to as "year round" or "indoor allergies" and is characterized by allergic symptoms that last longer than four weeks. House dust mites, animal dander, and mold most commonly trigger PAR. Chronic Idiopathic Urticaria (CIU) is most commonly known as "chronic hives of unknown origin" and is defined as the occurrence of daily, or almost daily, wheals and itching for at least six weeks with no obvious causes.

About Xyzal

Indications and Important Safety Information

Xyzal (levocetirizine dihydrochloride) is a prescription medication used to treat the symptoms of year round allergies, as well as a treatment for chronic hives and rashes of unknown cause (also known as chronic idiopathic urticaria) in patients 6 months of age and older, and symptoms of seasonal allergies in patients 2 years of age and older.

Do not take Xyzal if you are allergic to Xyzal , cetirizine or Zyrtec. Be sure to tell your doctor if you have kidney disease. Children 6 months to 11 years of age with impaired kidney function should not take Xyzal . Patients taking Xyzal should avoid operating machinery or driving a motor vehicle.

In patients 12 years of age and older, side effects may include sleepiness, tiredness, sore throat and dry mouth. In children 6-12 years of age, side effects may include fever, cough, sleepiness and nose bleeds. In children 1-5 years of age, side effects may include fever, diarrhea, vomiting, and ear infections. In children 6 months to 11 months of age, side effects may include diarrhea and constipation.

For full prescribing information please go to www.Xyzal.com.

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing approximately 10,000 people in over 40 countries, UCB generated revenue of EUR 3.6 billion in 2008. UCB is listed on Euronext Brussels (symbol: UCB). U.S. headquarters is located in Atlanta, Ga.

Forward-looking statement

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.

About sanofi-aventis

Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global pharmaceutical company that discovers, develops and distributes therapeutic solutions to improve the lives of patients. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE:SNY) .

Forward-looking statement

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, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

Xyzal is a trademark of the UCB Group of Companies

Source: UCB; sanofi-aventis

CONTACT: Eric Miller of UCB, +1-770-970-8569, eric.miller@ucb.com; or
Amy Ba of sanofi-aventis, +1-908-981-6563, amy.ba@sanofi-aventis.com

Web Site: http://www.xyzal.com/

Posted: August 2009

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Xyzal (levocetirizine dihydrochloride) FDA Approval History

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