FDA Approves New Use for Xyzal: Allergic Rhinitis and Chronic Idiopathic Urticaria

JB Editor
  • According to a press release from the drug company:

     

    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 used to relieve 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.

    • Seasonal allergic rhinitis (SAR), is better known as "hay fever" or "outdoor allergies" and includes allergies to seasonal pollens like grass, trees, and weeds, as well as mold. Hay fever is the most common form of allergic rhinitis.
    • Perennial Allergic Rhinitis (PAR) is sometimes referred to as "year round" or "indoor allergies" and is characterized by allergic symptoms that last longer than four weeks. House dust mites, animal dander, and mold most commonly trigger PAR.
    • Chronic Idiopathic Urticaria (CIU) is most commonly known as "chronic hives of unknown origin" and is defined as the occurrence of daily, or almost daily, wheals and itching for at least six weeks with no obvious causes.

    Xyzal is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.

    SOURCE: UCB and sanofi-aventis

    For more information see:

    How Can You Know Which Allergy Medicine Is Best?

    New Prescription Allergy Medicine: Xyzal

    Itchy Skin and Daily Hives -- Causes and Treatment
     

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Published On: February 20, 2008