FDA Approves NDA of Oral Allergy Drug
Posted on: Tuesday, 19 February 2008, 12:00 CST
UCB and Sanofi-aventis have announced that the FDA approved a new drug application for Xyzal 0.5mg/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.
Xyzal tablets received FDA approval on May 25, 2007 and both formulations are now approved for use in adults and children 6 years and older. 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.
Michael Blaiss, clinical professor of pediatrics and medicine at the University of Tennessee Health Science Center in Memphis, Tennessee, said: "Both the oral solution and tablets offer patients powerful and long-lasting allergy relief."
Source: Datamonitor
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