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FDA Approves XYZAL(R) For Use In Children Age Six Months And Older For The Relief Of Perennial Allergic Rhinitis And Chronic Idi

Posted Aug 25 2009 7:22pm
/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.

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