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Data updated: May 26, 2026

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE (sodium ferric gluconate complex)

Renal Approved 2011-03-31

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE is indicated for the treatment of Iron Deficiency Anemia; Chronic Kidney Disease.

Source: FDA Label • Hikma • Parenteral Iron Replacement

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.

Source: FDA Label
1
Indication
--
Phase 3 Trials
15
Years on Market

Details

Status
Prescription
First Approved
2011-03-31
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: SODIUM FERRIC GLUCONATE COMPLEX

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE Approval History

2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2011 to 2025
Sep 2025 SUPPL
Label · Labeling
Feb 2012 SUPPL
Label · Labeling
Mar 2011 ORIGINAL
Update

What SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE Treats

2 indications

SODIUM 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
Source: FDA Label

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE 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 SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

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Shared indications:
Chronic Kidney DiseaseIron Deficiency Anemia
FERAHEME
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AZURITY
Shared indications:
Iron Deficiency AnemiaChronic Kidney Disease
FERRLECIT
SODIUM FERRIC GLUCONATE COMPLEX
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Sanofi
Shared indications:
Iron Deficiency AnemiaChronic Kidney Disease
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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.

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE FDA Label Details

Indications & Usage

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE is indicated for the treatment of Iron Deficiency Anemia; Chronic Kidney Disease.

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Data Sources

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