4 March 2009
European approvals for Levocetirizine
Synthon announced today that it has successfully concluded its registration procedures for Levocetirizine. Regulatory clearance has been obtained for Synthon's product in fourteen European countries using decentralized procedures. Registration has been established for 5 mg filmcoated tablets. Synthon's product is a fully bioequivalent version of the oral anti-histamine drug Xyzal®. The product contains the active ingredient levocetirizine, which is the enantiopure form of cetirizine, the active ingredient in UCB’s product Zyrtec®.
Levocetirizine is the active ingredient of UCB’s brand product Xyzal®. Xyzal® is indicated for the treatment of chronic idiopathic urticaria and for relief of symptoms associated with allergic rhinitis. European sales of Xyzal® in 2008 were 155 million Euros based on IMS Midas data.

Xyzal® and Zyrtec® are trademarks of UCB.
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