Xyzal oral solution cleared by US FDA

Belgian drugmaker UCB and French drug major Sanofi-Aventis say that the US Food and Drug Administration has approved a New Drug Application for Xyzal (levocetirizine dihydrochloride) 0.5mg/mL oral solution, a prescription antihistamine indicated for the relief of symptoms associated with indoor and outdoor allergies, as well as for chronic idiopathic urticaria. Xyzal tablets received FDA approval on May 25, 2007, and both formulations are now cleared for use in adults and children six years of age and older (Marketletter June 4, 2007).

"The oral solution of Xyzal provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication," said Michael Blaiss, 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," he added.

In September 2006, UCB and Sanofi-Aventis entered into an agreement to launch and co-market Xyzal in the USA (Marketletter October 2, 2006). Studies in allergic rhinitis patients demonstrated the agent significantly reduced the symptoms of sneezing, itchy nose, runny nose and itchy eyes. Trials of the agent in chronic idiopathic urticaria patients showed levocetirizine significantly reduced the severity of itching and the number and size of wheals, the firms noted.