NDAINTRAVENOUSSOLUTION3 Generics Approved
Approved
Oct 2019
Lifecycle
Peak
Competitive Pressure
38/100
Clinical Trials
5
Data completeness
4/8 — Partial
Drug data last refreshed 11h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QUZYTTIR is an intravenous formulation of cetirizine hydrochloride, a second-generation histamine H1-receptor antagonist approved in 2019. It is indicated for acute urticaria and other allergic conditions requiring rapid systemic antihistamine delivery. The drug works by competitively blocking H1 receptors on mast cells and basophils, reducing histamine-mediated allergic responses.
$0.616MPart D
LOE Approaching3.4 years to LOENiche IV antihistamine at peak lifecycle with modest Part D penetration; commercial team likely lean and focused on hospital/acute care channels.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine
Started Mar 2020
34 enrolled
Oncology Patients Receiving Chemotherapy
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition
Started Jan 2006
30 enrolled
Healthy
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition
Started Jan 2006
30 enrolled
Healthy
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions
Started Jul 2005
40 enrolled
Allergies
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions
Started Jun 2005
40 enrolled
Allergies
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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.