NDAORALTABLET, CHEWABLE
Approved
Mar 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
5/8 — Partial
CHILDREN'S ZYRTEC ALLERGY (cetirizine hydrochloride) by Dr. Reddy's Laboratories is mechanism of actions cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral h 1 receptors. Approved for seasonal allergic rhinitis. First approved in 2004.
Drug data last refreshed 1w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Children's Zyrtec Allergy is a chewable tablet formulation of cetirizine hydrochloride, a second-generation antihistamine indicated for seasonal allergic rhinitis. It works by selectively inhibiting peripheral H1 receptors with negligible central nervous system penetration, making it suitable for pediatric use. The drug has been approved since 2004 and represents a well-established, safe option for allergy management in children.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), signaling potential team restructuring and shift toward generic optimization or line extensions.
Mechanism of Action
Mechanism of Actions Cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H 1 receptors. The antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models. In vivo…
Indications (1)
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.