sanofi-aventis (EPA:SAN) and UBC announced that the U.S. Food and Drug Administration has approved a New Drug Application (NDA) for Xyzal (levocetirizine dihydrochloride) 0.5 mg/ml oral solution.
Xyzal is an oral antihistamine, available only by prescription, for the relief of symptoms associated with indoor and outdoor allergies and is also indicated for the treatment of chronic idiopathic urticaria.
The tablet form of Xyzal received FDA approval in May, 2007 and both the tablet and oral formulations are now approved for use in adults and children over the age of 6.
"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 Paediatrics and Medicine at the University of Tennessee Health Science Centre in Memphis, Tennessee. "Both the oral solution and tablets offer patients powerful and long-lasting allergy relief."
