sanofi-aventis (EPA:SAN) and UBC announced that the U.S. Food and Drug Administration has approved a New Drug Application (NDA) for Xyzal (levocetirizine dihydrochloride) 0.5 mg/ml oral solution.
Xyzal is an oral antihistamine, available only by prescription, for the relief of symptoms associated with indoor and outdoor allergies and is also indicated for the treatment of chronic idiopathic urticaria.
The tablet form of Xyzal received FDA approval in May, 2007 and both the tablet and oral formulations are now approved for use in adults and children over the age of 6.
"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 showed that levocetirizine dihydrochloride significantly reduced symptoms of sneezing, itchy and runny nose, and itchy eyes. It is estimated that more than 20% of the U.S. population suffer from allergies
The most common side effects include fatigue, dry mouth, nasopharyngitis and drowsiness.
UCB and sanofi-aventis entered into an agreement to co-launch and market Xyzal in the U.S. in 2006.
"We are excited about the FDA approval of XYZAL(R) and our partnership with UCB," said Brent Ragans, Vice President, Specialty Markets, sanofi- aventis. "Building upon our long history in the allergy treatment arena, this opportunity allows us to continue our leadership position in this field and demonstrates our commitment to providing new treatments for the millions of allergy sufferers in the U.S."
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