Albuminex (albumin (human)-kjda) · Bio Products Laboratory
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.
Details
- Status
- Prescription
- First Approved
- 2018-06-18
- Routes
- Intravenous
- Dosage Forms
- Solution
Companies
Albuminex Approval History
What Albuminex Treats
9 indicationsAlbuminex 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
Albuminex Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
Drugs Similar to Albuminex
3 of 8FDA-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.
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.