Xyzal Now Approved for OTC Use

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Sanofi announced today that the FDA has approved its 24-hour formulation of levocetirizine dihydrochloride (Xyzal Allergy 24HR) for the over-the-counter (OTC) treatment of symptoms associated with seasonal and year-round allergies.

Sanofi announced today that the FDA has approved its 24-hour formulation of levocetirizine dihydrochloride (Xyzal Allergy 24HR) for OTC treatment of symptoms associated with seasonal and year-round allergies.

Xyzal, an antihistamine, was previously available only as a prescription medication. It is the third of Sanofi’s prescription drugs to make the jump to OTC shelves, following fexofenadine (Allegra Allergy) in 2011 and triamcinolone acetonide (Nasacort Allergy 24 HR) in 2013.

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

Sanofi plans to launch Xyzal Allergy 24HR as 5-mg tablets (for patients 6 years and older) and a 0.5-mg/mL oral solution (for patients 2 years and older) in spring 2017.

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