UCB, Inc. announced the submission of a New Drug Application to the United States Food and Drug Administration for the approval of Xyzal a new prescription antihistamine for treatment of allergy symptoms. Xyzal was basically launched first in Europe in 2001 and is currently marketed in 49 countries around the world. Xyzal has shown efficacy in treating a variety of allergies, meaning it could represent a new option for the physicians who treat allergy sufferers.

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UCB had recently submitted a New Drug Application for Xyzal, which UCB believes demonstrates safety and effectiveness as supported by clinical trials. Xyzal is intended to be used as a once-daily antihistamine for which UCB has requested the indications: symptomatic treatment of seasonal Allergic Rhinitis, Perennial Allergic Rhinitis, and Chronic Idiopathic Urticaria in adults and children six years of age and older.

If approved, Xyzal will offer the U.S. physicians who generally treat allergy patients a new option to control their allergy symptoms. Xyzal is available in many countries around the world. UCB had requested as part of the FDA application, the following indications: Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis, and Chronic Idiopathic Urticaria.

The NDA submission for Xyzal as an alternative for U.S. physicians seeking an effective prescription treatment for patients who do not experience relief with existing medicines.

Allergic Rhinitis affects almost 40 million people in the United States. Xyzal, when approved and available from UCB, will represent another option for many sufferers whose allergy symptoms are uncontrolled by the currently available therapies.