February 01, 2017
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FDA approves OTC Xyzal to treat allergies

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Today, Sanofi announced that Xyzal Allergy 24HR has been approved by the FDA for over-the-counter use to relieve seasonal and year-round allergy symptoms, according to a press release.

Xyzal is a single daily dose oral antihistamine, with an active ingredient of levocetirizine dihydrochloride, that relieves runny nose, sneezing, itchy watery eyes and itching of the nose or throat for 24-hours.

The FDA approved two formulations of Xyzal for over-the-counter (OTC) use — 5 mg tablets for patients aged 6 years and older and 0.5 mg/mL oral solution for patients aged 2 years and older.

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

Xyzal will be available in Spring 2017, according to Sanofi.

Disclosure: Robert Long is head of North America Consumer Healthcare, Sanofi.