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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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.