NUTRILIPID 20% (soybean oil)
Nutrilipid 20% is a lipid emulsion indicated as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is impossible, insufficient, or contraindicated. It is also used to treat or prevent essential fatty acid deficiency (EFAD).
How NUTRILIPID 20% Works
Nutrilipid 20% provides biologically utilizable fatty acids that serve as an important substrate for energy production, primarily via beta-oxidation. These fatty acids are essential for cell membrane structure and function, act as precursors for bioactive molecules such as prostaglandins, and serve as regulators of gene expression. Administration results in increased heat production, increased oxygen consumption, and a decrease in the respiratory quotient.
Details
- Status
- Prescription
- First Approved
- 1993-05-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NUTRILIPID 20% Approval History
What NUTRILIPID 20% Treats
3 indicationsNUTRILIPID 20% is approved for 3 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nutritional deficiency requiring parenteral nutrition
- Essential fatty acid deficiency
- Inadequate oral or enteral nutrition
NUTRILIPID 20% 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.
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.
NUTRILIPID 20% FDA Label Details
Indications & Usage
FDA Label (PDF)NUTRILIPID 20% is indicated for the treatment of Nutritional deficiency requiring parenteral nutrition; Essential fatty acid deficiency; Inadequate oral or enteral nutrition.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.