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The FDA has approved a New Drug Application (NDA) for Xyzal® (levocetirizine dihydrochloride) 0.5mg/ml oral solution, a prescription antihistamine indicated for relief of symptoms associated with indoor and outdoor allergies and treating chronic idiopathic urticaria, according to manufacturers UCB and Sanofi-Aventis.
Levocetirizine dihydrochloride tablets gained FDA approval in May 2007 and both formulations are now approved for use in adults and children six years and older.
Dr Michael Blaiss, clinical professor of paediatrics and medicine at the University of Tennessee Health Science Center, USA, said: “The oral solution of Xyzal provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication.
“Both the oral solution and tablets offer patients powerful and long-lasting allergy relief.”
The manufacturers said studies in allergic rhinitis patients demonstrated that 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 and Sanofi-Aventis agreed to launch and co-market Xyzal in the USA.
