The Food and Drug Administration has approved Xyzal Allergy 24HR (levocetirizine dihydrochloride) as an over-the-counter treatment to alleviate symptoms of seasonal and year-round allergies, Sanofi said Wednesday.
The product offers proven 24-hour relief from runny nose, sneezing, itchy watery eyes and itching of the nose or throat in one daily dose, according to the company.
Two formulations of Xyzal were approved for OTC use: 5-mg tablets for people ages 6 and older and an 0.5 mg/ml oral solution for ages 2 and older.
Sanofi said Xyzal Allergy 24HR is expected to begin shipping in the spring.
“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,” stated Robert Long, head of North America Consumer Healthcare at Sanofi. “We look forward to making it available to allergy sufferers across the country, as the latest product in our growing consumer health care business.”
Sanofi Consumer Healthcare’s allergy portfolio already includes Allegra Allergy, which was approved for OTC use in 2011, and Nasacort Allergy 24HR, approved for OTC use in 2013.