NDAORALSUSPENSION
Approved
Jan 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
6
Data completeness
4/8 — Partial
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Children's Allegra Allergy is an oral suspension formulation of fexofenadine hydrochloride, a selective H1-receptor antagonist indicated for pediatric allergy symptom relief. It is a non-drowsy antihistamine designed to reduce itching, sneezing, runny nose, and other allergic rhinitis symptoms in children.
Peak4.1 years to LOE
Peak-stage product at Sanofi with established pediatric market position; commercial teams focus on maintaining market share against generic and OTC competition.
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 (6)
Study to Assess Safety and Efficacy of Fexofenadine Hydrochloride (HCL) + Pseudoephedrine HCL Fixed Dose Combination in Indian Male and Female Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above
Started Jun 2025
203 enrolled
Rhinitis Allergic
Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
Started Feb 2011
80 enrolled
Healthy
Bioequivalence Study of Dr. Reddy's Laboratories Limited Fexofenadine Hydrochloride 180 mg Tablets Under Fed Conditions
Started Apr 2002
30 enrolled
Healthy
Bioequivalence Study of Dr.Reddy's Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions
Started Apr 2002
44 enrolled
Healthy
Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions
Started Mar 2002
60 enrolled
Healthy
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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.