Sanofi's Xyzal Allergy 24HR Approved for OTC Use in the United States

Sanofi announced that the U.S. Food and Drug Administration (FDA) approved Xyzal Allergy 24HR as an over-the-counter (OTC) treatment for the relief of symptoms associated with seasonal and year-round allergies. Specifically, two formulations of Xyzal are now approved for OTC use – 5 mg tablets for ages 6 years and older, as well as 0.5 mg/mL oral solution for ages 2 years and older. Xyzal is an oral antihistamine with a proven 24-hour effect.

“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,” said Robert Long, Head of North America Consumer Healthcare, Sanofi. “We look forward to making it available to allergy sufferers across the country, as the latest product in our growing consumer healthcare business.”

As many as 60 million Americans suffer from allergic rhinitis, which is also commonly known as hay fever. Antihistamines are the most widely used medications to relieve hay fever symptoms. Xyzal is an antihistamine that contains the active ingredient levocetirizine dihydrochloride, which has a well-established safety and efficacy profile. It offers 24-hour relief from runny nose, sneezing, itchy watery eyes and itching of the nose or throat, all in a single daily dose.

Sanofi Consumer Healthcare’s existing allergy portfolio includes Allegra Allergy, which was approved for OTC use in 2011 and Nasacort Allergy 24HR, which was approved for OTC use in 2013. The company anticipates that Xyzal will be made available in Spring 2017.