US FDA clears UCB/Sanofi-Aventis' Xyzal for children

Belgium drugmaker UCB and French partner Sanofi-Aventis's US subsidiary say that the US Food and Drug Administration 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, clinical professor of pediatrics and medicine at the University of Tennessee Health Science Center, USA and past president of the American College of Allergy, Asthma, and Immunology 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 4% of US children. Recognizing the symptoms and increased hereditary risk are key elements to ensuring early diagnosis and proper management.

Xyzal tablets received FDA approval on May 25, 2007 and the oral solution was cleared by the agency on February 19, 2008.