TheraRadar
Data updated: May 26, 2026

AKOVAZ (ephedrine sulfate)

Cardiovascular Approved 2016-04-29

AKOVAZ is indicated for the treatment of Hypotension.

Source: FDA Label • EXELA PHARMA

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.

1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Prescription
First Approved
2016-04-29
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: EPHEDRINE SULFATE

AKOVAZ Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2016 to 2021
Aug 2021 SUPPL
Mfg · Manufacturing (CMC)
Apr 2020 SUPPL
Label · Labeling
Aug 2018 SUPPL
Label · Labeling

What AKOVAZ Treats

1 indications

AKOVAZ is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypotension
Source: FDA Label

AKOVAZ Competitive Set

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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.

AKOVAZ FDA Label Details

Indications & Usage

FDA Label (PDF)

AKOVAZ is indicated for the treatment of Hypotension.

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Data Sources

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