www.fdanews.com/articles/61272-ucb-submits-nda-for-rhinitis-treatment
UCB SUBMITS NDA FOR RHINITIS TREATMENT
July 28, 2006
UCB has submitted a new drug application (NDA) to the FDA for Xyzal (levocetirizine dihydrochloride), a new prescription antihistamine for treatment of allergy symptoms.
UCB requested as part of the FDA application the following indications: seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria in adults and children 6 and older.
The drug was first launched in Europe in 2001 and is currently marketed in 49 countries.