KOVANAZE
Details
- Status
- Prescription
- First Approved
- 2016-06-29
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
Companies
KOVANAZE Approval History
What KOVANAZE Treats
5 indicationsKOVANAZE is approved for 5 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nasal Congestion
- Common Cold
- Hay Fever
- Upper Respiratory Allergy
- Sinus Congestion
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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.
KOVANAZE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Uses • temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies • temporarily relieves sinus congestion and pressure • shrinks swollen nasal membranes so you can breathe more freely
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.