UCB and sanofi-aventis announced that the US 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.
"The oral solution of Xyzal provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication," said Michael S. Blaiss, MD, Clinical Professor of Paediatrics and Medicine at the University of Tennessee Health Science Centre in Memphis, Tennessee. "Both the oral solution and tablets offer patients powerful and long-lasting allergy relief."
Studies in allergic rhinitis patients demonstrated levocetirizine significantly reduced the symptoms of sneezing, itchy nose, runny nose, and itchy eyes. Studies in chronic idiopathic urticaria patients showed levocetirizine significantly reduced the severity of itching and the number and size of wheals.
In September 2006, UCB and sanofi-aventis entered into an agreement to launch and co-market Xyzal in the US UCB and sanofi-aventis have a long history in the allergy treatment arena and are committed to advancing treatment for allergy sufferers and helping meet unmet medical needs for patients with chronic allergy symptoms.
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.
The use of Xyzal is contraindicated in: patients with a known hypersensitivity to levocetirizine or any of the ingredients of Xyzal or to cetirizine (observed reactions range from urticaria to anaphylaxis); patients with end-stage renal impairment at less than 10 mL/min creatinine clearance or patients undergoing haemodialysis; and paediatric patients aged 6 to 11 years with impaired renal function.
Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination, such as operating machinery or driving a motor vehicle, after ingestion of Xyzal. Concurrent use of Xyzal with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.
UCB, Brussels, Belgium is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris and in New York.