Production & Manufacturing

FDA approves Sanofi's Xyzal Allergy 24HR for OTC use

PBR Staff Writer Published 02 February 2017

Sanofi has secured approval from the US Food and Drug Administration (FDA) for 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.

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.

The FDA approved two formulations of Xyzal for 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 company expects to launch both products in spring 2017.

Sanofi head of North America consumer healthcare Robert Long said: "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.

"We look forward to making it available to allergy sufferers across the country, as the latest product in our growing consumer healthcare business."

Sanofi is organized into five worldwide business units that include Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare.

The existing allergy portfolio of Sanofi Consumer Healthcare includes Allegra Allergy, which secured approval for OTC use in 2011 and Nasacort Allergy 24HR, which was approved for OTC use in 2013.

Image: Sanofi head of North America consumer healthcare Robert Long. Photo: courtesy of sanofi-aventis U.S. LLC.