AKOVAZ (ephedrine sulfate) · EXELA PHARMA
Akovaz (ephedrine sulfate) is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. It is used to stabilize blood pressure levels during surgical procedures to maintain hemodynamic stability.
How AKOVAZ Works
Ephedrine sulfate is a sympathomimetic amine that acts as a direct agonist at alpha- and beta-adrenergic receptors and indirectly induces the release of norepinephrine from sympathetic neurons. These actions increase blood pressure through elevated cardiac output, increased peripheral resistance, and higher arterial pressure.
Details
- Status
- Prescription
- First Approved
- 2016-04-29
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
AKOVAZ Approval History
What AKOVAZ Treats
1 indicationsAKOVAZ is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
AKOVAZ Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
AKOVAZ FDA Label Details
Indications & Usage
FDA Label (PDF)AKOVAZ (ephedrine sulfate injection) is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. AKOVAZ injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.