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UCB/Sanofi Xyzal approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

UCB and Sanofi-Aventis plan to launch the antihistamine Xyzal (levocetirizine) in the U.S. in time for the fall allergy season, the companies said. FDA approved the once-daily H1 receptor antagonist May 25 for the relief of symptoms associated with seasonal and perennial allergic rhinitis and for the treatment of uncomplicated skin manifestations of chronic urticaria in adults and children 6 years of age and older. Firms plan to jointly promote Xyzal in the U.S. using a combined field force of 1,000 sales reps. Timing of the launch will fall just ahead of when UCB/Pfizer's Zyrtec (cetirizine) is scheduled to go off patent later this year. However, UCB/Sanofi could face competition from over-the-counter H1 receptor antagonists such as loratadine (Schering-Plough's Claritin and generics). Johnson & Johnson is planning to launch OTC Zyrtec in late 2007 after acquiring the OTC licensing rights through its purchase of Pfizer Consumer Healthcare in December...

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