FDA approves labeling supplement for Children's Xyzal Allergy 24HR oral solution
Chattem Sanofi received FDA approval for an eighth supplement to its NDA for the pediatric levocetirizine allergy solution.
This week's update covers a single regulatory action affecting Chattem Sanofi's pediatric allergy product.
- The FDA approved Supplement 8 for CHILDRENS XYZAL ALLERGY under NDA209090, a labeling submission for an oral solution containing levocetirizine dihydrochloride at 2.5MG/5ML, marketed as XYZAL ALLERGY 24HR.1 The submission carried standard review priority and was approved with a submission status date of 2026-08-31.
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