Overview
Edetate calcium disodium is a metal ion chelator used to reduce blood concentrations and depot stores of lead from the body. It is on the World Health Organization Model List of Essential Medicines. Edetate calcium disodium was granted FDA approval on 16 July 1953.
Background
Edetate calcium disodium is a metal ion chelator used to reduce blood concentrations and depot stores of lead from the body. It is on the World Health Organization Model List of Essential Medicines. Edetate calcium disodium was granted FDA approval on 16 July 1953.
Indication
Edetate calcium disodium is indicated to reduce blood levels and depot stores of lead in acute and chronic lead poisoning.
Associated Conditions
- Lead Poisoning
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/08/15 | Phase 1 | Recruiting | |||
2015/04/20 | Phase 4 | Withdrawn | Mt. Sinai Medical Center, Miami | ||
2010/04/12 | Phase 1 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| BTG International Inc | 50633-320 | INTRAVENOUS | 50 mg in 1 mL | 10/20/2022 | |
| Casper Pharma LLC | 70199-034 | INTRAMUSCULAR, INTRAVENOUS | 200 mg in 1 mL | 10/28/2022 | |
| Rising Pharmaceuticals, Inc. | 64980-588 | INTRAMUSCULAR, INTRAVENOUS | 200 mg in 1 mL | 5/5/2023 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||