Sanofi, the parent company of Chattem, says that the U.S. Food and Drug Administration (FDA) has approved Xyzal Allergy 24HR as an over-the-counter treatment for the relief of symptoms associated with seasonal and year-round allergies.
"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."
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.
The drug gives users 24-hour relief from a runny nose, sneezing, itchy watery eyes and itching of the nose or throat, all in a single daily dose, according to Sanofi.
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.