DEXMEDETOMIDINE HYDROCHLORIDE
Details
- Status
- Prescription
- First Approved
- 2014-08-18
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, SOLUTION
Companies
DEXMEDETOMIDINE HYDROCHLORIDE Approval History
What DEXMEDETOMIDINE HYDROCHLORIDE Treats
1 indicationsDEXMEDETOMIDINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Sedation
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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.
DEXMEDETOMIDINE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Dexmedetomidine hydrochloride is a alpha 2 -adrenergic receptor agonist indicated for: • Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride by continuous infusion not to exceed 24 hours. • Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. 1.1 Intensive Care Unit Sedation Dexmedetomidine Injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmed...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.