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Published on 25 February 2008

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FDA approves new drug application for Xyzal

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The US Food and Drug Administration (FDA), has approved a New Drug Application (NDA) for Xyzal® (levocetirizine dihydrochloride) 0.5 mg/mL oral solution, a prescription antihistamine indicated for the relief of symptoms associated with indoor and outdoor allergies, as well as the treatment of chronic idiopathic urticaria.

“The oral solution of XYZAL provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication,” said Michael S Blaiss, MD, Clinical Professor of Pediatrics and Medicine at the University of Tennessee Health Science Center in Memphis, Tennessee.

“Both the oral solution and tablets offer patients powerful and long-lasting allergy relief,” said Dr Blaiss.

Studies in allergic rhinitis patients demonstrated levocetirizine significantly reduced the symptoms of sneezing, itchy nose, runny nose, and itchy eyes. Studies in chronic idiopathic urticaria patients showed levocetirizine significantly reduced the severity of itching and the number and size of wheals.

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

Xyxal tablets received FDA approval on May 25, 2007, and both formulations are now approved for use in adults and children six years and older.

US Food and Drug Administration



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