CORRECTED - FDA approves UCB/Sanofi's Xyzal oral solution

Tue Feb 19, 2008 10:55am EST
 
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(Corrects spelling of drug in headline and text)

PARIS, Feb 19 (Reuters) - French drug group Sanofi-Aventis (SASY.PA) and Belgium's UCB (UCB.BR) said on Tuesday that the Food and Drug Administration (FDA) approved a New Drug Application (NDA) for Xyzal (levocetirizine dihydrochloride) 0.5 mg/mL oral solution.

Xyzal is 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 six years and older.

In September 2006, UCB and Sanofi-Aventis entered into an agreement to launch and comarket Xyzal in the U.S. (Reporting by Marcel Michelson)

 
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