TheraRadar

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Data updated: Mar 10, 2026

KOVANAZE

OXYMETAZOLINE HYDROCHLORIDE
Respiratory Approved 2016-06-29
1
Indication
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2016-06-29
Routes
NASAL
Dosage Forms
SPRAY, METERED

KOVANAZE Approval History

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What KOVANAZE Treats

5 indications

KOVANAZE 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
Source: FDA Label

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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

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Indications & 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

KOVANAZE Patents & Exclusivity

Latest Patent: Apr 2030

Patents (2 active)

US9308191 Expires Apr 2, 2030
US8580282 Expires Apr 2, 2030
Source: FDA Orange Book

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.