ETOMIDATE
Details
- Status
- Prescription
- First Approved
- 1996-11-04
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ETOMIDATE Approval History
What ETOMIDATE Treats
11 FDA approvalsOriginally approved for its first indication in 1996 . Covers 11 distinct patient populations.
- Other (11)
Other
(11 approvals)- • Approved indication (Nov 1996)
- • Approved indication (Jan 2009)
- • Approved indication (Dec 2009)
- • Approved indication (Jun 2012)
- • Approved indication (Jul 2014)
- • Approved indication (Aug 2014)
- • Approved indication (Feb 2016)
- • Approved indication (Feb 2017)
- • Approved indication (Feb 2017)
- • Approved indication (Apr 2017)Letter
- • Approved indication (Dec 2020)
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.
ETOMIDATE FDA Label Details
ProIndications & Usage
Etomidate Injection is indicated by intravenous injection for the induction of general anesthesia. When considering use of Etomidate Injection, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ). Intravenous Etomidate Injection is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.