SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE (sodium ferric gluconate complex) · Hikma
Sodium ferric gluconate complex in sucrose is an injectable iron replacement product indicated for the treatment of iron deficiency anemia in adult and pediatric patients (6 years and older) with chronic kidney disease who are receiving hemodialysis and supplemental epoetin therapy. It is used to restore iron levels to support hemoglobin synthesis and maintain proper oxygen transport.
How SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE Works
This agent replenishes the body's iron stores, providing the essential component for hemoglobin synthesis and the maintenance of systemic oxygen transport. Additionally, it provides the iron necessary for various metabolic and enzymatic processes throughout the body.
Details
- Status
- Prescription
- First Approved
- 2011-03-31
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE Approval History
What SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE Treats
2 indicationsSODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Iron Deficiency Anemia
- Chronic Kidney Disease
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
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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.
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Trial Timeline
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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.
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE FDA Label Details
Indications & Usage
Sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. Sodium ferric gluconate complex in sucrose injection is an iron replacement product for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.