Overview
Ferric Carboxymaltose is an iron replacement product and chemically, an iron carbohydrate complex. FDA approved on July 25, 2013.
Indication
Ferric carboxymaltose is an iron replacement product indicated for the treatment of iron deficiency anemia in patients ≥1 year of age who have an intolerance to, or unsatisfactory response from, oral iron therapy. It is also indicated in adult patients who have non-dialysis-dependent chronic kidney disease.
Associated Conditions
- Iron Deficiency Anemia (IDA)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/10 | Not Applicable | Recruiting | |||
2025/07/08 | Not Applicable | Recruiting | Syed Hamza Mufarrih | ||
2025/04/04 | Phase 4 | Completed | CMH Multan Institute of Medical Sciences | ||
2025/03/26 | Phase 1 | Completed | |||
2024/11/13 | Phase 4 | Recruiting | United States Army Research Institute of Environmental Medicine | ||
2024/05/31 | Not Applicable | Active, not recruiting | Akram Medical Complex | ||
2024/05/30 | Phase 3 | Not yet recruiting | |||
2024/04/08 | Phase 4 | Recruiting | Lucie Favre | ||
2023/10/12 | Phase 4 | Completed | |||
2023/10/12 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| American Regent, Inc. | 0517-0620 | INTRAVENOUS | 50 mg in 1 mL | 6/6/2023 | |
| American Regent, Inc. | 0517-0650 | INTRAVENOUS | 50 mg in 1 mL | 6/6/2023 | |
| American Regent, Inc. | 0517-0602 | INTRAVENOUS | 50 mg in 1 mL | 6/6/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Ferinject Solution for Injection 50mg/ml | SIN14035P | INJECTION, SOLUTION | 50 mg/ml | 10/19/2011 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FERINJECT iron (as ferric carboxymaltose) 500mg/10mL injection vial | 162641 | Medicine | A | 4/21/2011 | |
| FERINJECT iron (as ferric carboxymaltose) 100mg/2mL injection vial | 162636 | Medicine | A | 4/21/2011 | |
| FERINJECT iron (as ferric carboxymaltose) 1000 mg/20 mL injection vial | 289045 | Medicine | A | 6/5/2018 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.