February 19, 2008 -
UCB and
sanofi-aventis announced that the U.S. Food and Drug Administration (FDA) 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. 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...
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Many people suffer from the symptoms associated with common allergic conditions. The immune system of allergy sufferers over-reacts to something in the environment, leading to symptoms that affect their respiratory system, eyes, or skin. Estimates from the American Academy of Allergy, Asthma & Immunology (AAAAI) suggest that indoor and outdoor allergies affect as many as 40 million people in the United States...
UCB's press Release-
[PDF] sanofi-aventis' Press release-
PDF du Communiqué de Presse de sanofi-aventis-