Xyzal Allergy 24HR
What: The U.S. Food and Drug Administration has approved Xyzal Allergy 24HR as an over-the-counter treatment for the relief of symptoms associated with seasonal and year-round allergies. Chattanooga-based Chattem, the U.S. consumer health care division for pharmaceutical giant Sanofi, is overseeing the launch of the new medication, which is hitting stores this spring, according to the company.
Why: As many as 60 million Americans suffer from allergic rhinitis, which is also commonly known as hay fever. Antihistamines are the most widely used medications to relieve hay fever symptoms. Xyzal is an antihistamine that contains the active ingredient levocetirizine dihydrochloride, which has a well-established safety and efficacy profile, according to the company. It offers 24-hour relief from runny nose, sneezing, itchy watery eyes and itching of the nose or throat, all in a single daily dose.
Ways Offered: 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.
Where: Chattem's Chattanooga facilities will be used to package Xyzal Allergy 24HR, according to Robert Long, the company's chief executive. He says that packaging for Xyzal was essentially complete earlier this year, noting that part of the FDA approval process involves submitting labeling and packaging.
"They have to approve final language, graphics, font size," Long says.
Who: Chattem, a 138-year-old company started in Chattanooga, was bought in 2010 by French pharmaceutical titan Sanofi for $1.9 billion in cash. Chattem, which also makes consumer products such as Gold Bond, Icy Hot and Selsun Blue, has overseen successful prescription to over-the-counter switches of Allegra Allergy in 2011 and Nasacort Allergy 24HR in 2013.