AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY (azelastine hydrochloride) · Apotex
AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY is FDA-approved to treat 6 conditions (same as ASTEPRO).
Details
- Status
- Over-the-counter
- First Approved
- 2024-05-29
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY Approval History
What AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY Treats
6 indicationsAZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY is approved for 6 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hay Fever
- Upper Respiratory Allergy
- Nasal Congestion
- Runny Nose
- Sneezing
- Itchy Nose
Same approved indications as ASTEPRO (same active ingredient).
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05887843 | SAN-0791 2023-000362-34 | Ph 1 | terminated | Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis |
| NCT04729517 HILARIA | Aİ-2019-01 | Ph 3 | completed | Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients |
| NCT00612118 | IPR110982 | Ph 2 | completed | A Phase II Study Evaluating Intranasal GSK256066 and Azelastine Hydrochloride in Subjects With Seasonal Allergic Rhinitis |
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.
AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY FDA Label Details
Indications & Usage
AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY is FDA-approved to treat 6 conditions — same approved indications as ASTEPRO.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.