Over-the-Counter Allergy Drug Cleared in the US


The FDA approved an OTC oral histamine for pediatric allergy treatment.

The US Food and Drug Administration (FDA) approved the oral antihistamine levocetirizine (Xyzal/Sanofi) as an over-the-counter (OTC) pediatric treatment to relieve symptoms associated with seasonal and year-round allergies.

Two formulations of Xyzal were officially granted OTC approval: 5mg tablets for children 6 years and older and 0.5mg/mL oral solution for toddlers at least two years and older.

Nearly 60 million people suffer from allergic rhinitis (hay fever) in the US and are commonly given antihistamines for symptoms relief.

Researchers said in a news release that Xyzal contains the active ingredient levocetirizine dihydrochloride and a single daily dose provides 24-hour relief from itchy watery eyes, itching of the nose or throat, runny nose, and sneezing.

Robert Long, Head of North America Consumer Healthcare, Sanofi, concluded in the statement, “The FDA approval of Xyzal builds on our heritage of successful Rx-to-OTC switches, and adds another trusted option to our existing portfolio of OTC allergy medications.”

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