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FDA OKs Sanofi Allergy Drug for Younger Children

By Pharmaceutical Processing | August 25, 2009

WASHINGTON (AP) — Sanofi-Aventis SA and Belgian biotech drug maker UCB said Monday their once-daily allergy medication Xyzal has received expanded U.S. approval for children as young as six months. The FDA has approved the drug to treat indoor allergies and hives in children six months and older. The agency also cleared the drug for outdoor allergies in children older than two. Previously the drug, which is available in pill and liquid form, was approved to treat indoor and outdoor nasal allergies in children ages six and up. Company studies show that Xyzal significantly reduces sneezing, itchy nose, runny nose, and itchy eyes for hay fever, along with itching and the size of hive outbreaks. Sanofi and UCB co-market Xyzal in the U.S.

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