Posted from: Friday, March 03, 2017 - 04:58 PM - Present

Xyzal Approved to be Available Over-the-Counter

January 31, 2017 – The U.S.FDA approved Xyzal® (levocetirizine) for over-the-counter (OTC) status. Manufactured by Sanofi, Xyzal is used to treat both seasonal and chronic allergies and it is expected to be available before the spring allergy season. The OTC product will be marketed as Xyzal® Allergy 24HR and it will be available as 5mg tablets that are indicated for adults, teens and children as young as six years old A liquid form containing 0.5mg/mL may be used for children as young as two. One dose per day is taken in the evening.   

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Wednesday, October 16, 2019 - 09:15 PM.