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Data updated: Jun 28, 2026

Albuminex (albumin (human)-kjda) · Bio Products Laboratory

Cardiovascular Approved 2018-06-18

ALBUMINEX 25% is a 25% albumin solution indicated for adults and children : Hypovolemia Ascites Hypoalbuminemia including from burns Acute Nephrosis Acute Respiratory Distress Syndrome (ARDS) Cardiopulmonary Bypass ALBUMINEX 25% is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate e.g.

Source: FDA Label
BLA
Biologic
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2018-06-18
Routes
Intravenous
Dosage Forms
Solution

Albuminex Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2018 to 2018
Jun 2018 ORIGINAL
Update · CBER biologic (Purple Book)

What Albuminex Treats

9 indications

Albuminex is approved for 9 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypovolemia
  • Ascites
  • Hepatorenal Syndrome
  • Spontaneous Bacterial Peritonitis
  • Hypoalbuminemia
  • Burns
  • Hypoproteinemia
  • Acute Respiratory Distress Syndrome
  • Cardiopulmonary Bypass
Source: FDA Label

Albuminex Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to Albuminex

3 of 8

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OPTISON
ALBUMIN HUMAN
8 shared
GE HEALTHCARE
Shared indications:
HypovolemiaAscitesHypoalbuminemia +5 more
EDECRIN
ETHACRYNIC ACID
1 shared
BAUSCH
Shared indications:
Ascites
EPIOXA HD/EPIOXA KIT
RIBOFLAVIN 5'-PHOSPHATE SODIUM
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GLAUKOS
Shared indications:
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Active Pipeline

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Key Completed Trials

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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.

Albuminex FDA Label Details

Indications & Usage

ALBUMINEX 25% is a 25% albumin solution indicated for adults and children : Hypovolemia Ascites Hypoalbuminemia including from burns Acute Nephrosis Acute Respiratory Distress Syndrome (ARDS) Cardiopulmonary Bypass 1.1 Hypovolemia ALBUMINEX 25% is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate e.g. hypovolemia following shock due to trauma or sepsis, in surgical patients and in other similar conditions with volume deficiency when restoration and maintenance of circulating blood volume is r...

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Data Sources

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