NDAORALTABLETPriority Review
Approved
May 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
Priority Review
XYZAL (levocetirizine dihydrochloride) by Sanofi is levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via selective inhibition of h 1 receptors. Approved for allergic rhinitis, urticaria. First approved in 2007.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XYZAL (levocetirizine dihydrochloride) is an oral antihistamine and the active enantiomer of cetirizine, offering 2-fold higher H1-receptor affinity than its parent compound. It is indicated for allergic rhinitis and urticaria, providing symptom relief through selective H1-receptor inhibition. The drug is a small-molecule oral tablet approved since 2007.
LOE Approaching
As LOE approaches, the XYZAL brand team faces revenue pressure and likely smaller headcount compared to peak-stage products; roles will shift toward lifecycle extension and generic transition planning.
Mechanism of Action
Levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via selective inhibition of H 1 receptors. The antihistaminic activity of levocetirizine has been documented in a variety of animal and human models. In vitro binding studies revealed that…
Indications (2)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.