EDETATE CALCIUM DISODIUM
EDETATE CALCIUM DISODIUM is indicated for the treatment of Lead Poisoning; Lead Encephalopathy.
Details
- Status
- Prescription
- First Approved
- 2023-05-03
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
EDETATE CALCIUM DISODIUM Approval History
What EDETATE CALCIUM DISODIUM Treats
2 indicationsEDETATE CALCIUM DISODIUM is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Lead Poisoning
- Lead Encephalopathy
EDETATE CALCIUM DISODIUM Boxed Warning
WARNINGS Edetate calcium disodium injection is capable of producing toxic effects which can be fatal. Lead encephalopathy is relatively rare in adults, but occurs more often in pediatric patients in whom it may be incipient and thus overlooked. The mortality rate in pediatric patients has been high. Patients with lead encephalopathy and cerebral edema may experience a lethal increase in intracranial pressure following intravenous infusion; the intramuscular route is preferred for these patients....
WARNINGS Edetate calcium disodium injection is capable of producing toxic effects which can be fatal. Lead encephalopathy is relatively rare in adults, but occurs more often in pediatric patients in whom it may be incipient and thus overlooked. The mortality rate in pediatric patients has been high. Patients with lead encephalopathy and cerebral edema may experience a lethal increase in intracranial pressure following intravenous infusion; the intramuscular route is preferred for these patients. In cases where the intravenous route is necessary, avoid rapid infusion. The dosage schedule should be followed and at no time should the recommended daily dose be exceeded.
EDETATE CALCIUM DISODIUM 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.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03630991 | 2017-0752 NCI-2018-01610, 2017-0752 | Ph 1 | recruiting | Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy |
| NCT02421029 | MRI-EDTA | Ph 4 | withdrawn | Prolonged Gadolinium Retention After MRI Imaging |
Active Pipeline
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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.
EDETATE CALCIUM DISODIUM FDA Label Details
Indications & Usage
EDETATE CALCIUM DISODIUM is indicated for the treatment of Lead Poisoning; Lead Encephalopathy.
WARNINGS Edetate calcium disodium injection is capable of producing toxic effects which can be fatal. Lead encephalopathy is relatively rare in adults, but occurs more often in pediatric patients in whom it may be incipient and thus overlooked. The mortality rate in pediatric patients has been high....
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CALCIUM DISODIUM VERSENATE
Full clinical data, patents, trials, and competitive landscape for edetate calcium disodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.