CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochloride oral solution treats symptoms of year-round allergies in children between 6 and 23 months old. It helps patients with sneezing, runny nose, and itchy eyes caused by common triggers like dust mites, mold, and animal dander. This medication is also used for children up to 5 years of age to manage chronic hives by reducing the frequency and severity of skin outbreaks and itching.
How CETIRIZINE HYDROCHLORIDE Works
This medication works by selectively inhibiting peripheral H1 receptors to block the effects of histamine. As a metabolite of hydroxyzine, it targets these receptors outside of the central nervous system and shows negligible penetration into the brain. This targeted action helps manage allergic symptoms and skin reactions with minimal impact on other receptor types.
Details
- Status
- Discontinued
- First Approved
- 2008-05-27
- Routes
- ORAL
- Dosage Forms
- SOLUTION, TABLET, TABLET, ORALLY DISINTEGRATING
Companies
CETIRIZINE HYDROCHLORIDE Approval History
What CETIRIZINE HYDROCHLORIDE Treats
2 indicationsCETIRIZINE HYDROCHLORIDE is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Perennial allergic rhinitis
- Chronic idiopathic urticaria
CETIRIZINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CETIRIZINE HYDROCHLORIDE FDA Label Details
Indications & Usage
CETIRIZINE HYDROCHLORIDE is indicated for the treatment of Perennial allergic rhinitis; Chronic idiopathic urticaria.
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Full clinical data, patents, trials, and competitive landscape for cetirizine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.