ETHACRYNIC ACID
Ethacrynic acid tablets, USP are indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema.
Details
- Status
- Prescription
- First Approved
- 2016-06-30
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
ETHACRYNIC ACID Approval History
What ETHACRYNIC ACID Treats
10 FDA approvalsOriginally approved for its first indication in 2016 . Covers 10 distinct patient populations.
- Other (10)
Other
(10 approvals)- • Approved indication (Jun 2016)Label Letter
- • Approved indication (Feb 2017)
- • Approved indication (Jul 2017)
- • Approved indication (May 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Jul 2019)
- • Approved indication (Aug 2019)
- • Approved indication (Sep 2019)
- • Approved indication (Feb 2020)
- • Approved indication (Oct 2020)
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02852564 | 2015IITEthacrynicAcidBladderCa | Ph 1 | completed | Ethacrynic Acid Elimination in Non-Muscle Invasive Bladder Cancer Patients Undergoing Transurethral Resection |
| NCT01628731 | FUROCRYNIC trial-1 OBG DIURETICS | Ph 3 | completed | Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease |
Active Pipeline
Ongoing clinical trials by development phase
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.
ETHACRYNIC ACID FDA Label Details
Indications & Usage
FDA Label (PDF)Ethacrynic acid tablets, USP are indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desir...
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Full clinical data, patents, trials, and competitive landscape for ethacrynic acid.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.