HEPARIN SODIUM PRESERVATIVE FREE (heparin sodium)
Heparin Sodium Injection is indicated for: • Prophylaxis and treatment of venous thrombosis and pulmonary embolism; • Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; • Atrial fibrillation with embolization; • Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); • Prevention of clotting in arteri...
Details
- Status
- Prescription
- First Approved
- 1943-05-04
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HEPARIN SODIUM PRESERVATIVE FREE Approval History
What HEPARIN SODIUM PRESERVATIVE FREE Treats
12 FDA approvalsOriginally approved for its first indication in 1943 . Covers 12 distinct patient populations.
- Other (12)
Other
(12 approvals)- • Approved indication (May 1943)
- • Approved indication (Feb 1972)
- • Approved indication (Feb 1980)
- • Approved indication (May 1981)
- • Approved indication (May 1985)
- • Approved indication (Jul 1985)
- • Approved indication (Jun 1986)
- • Approved indication (May 1987)
- • Approved indication (Jun 2010)
- • Approved indication (Jul 2011)Label Letter
- • Approved indication (Jun 2014)
- • Approved indication (Apr 2020)
HEPARIN SODIUM PRESERVATIVE FREE Target & Pathway
ProTarget
A key enzyme in the blood clotting cascade that converts prothrombin to thrombin. Inhibiting Factor Xa prevents clot formation, reducing risk of stroke in atrial fibrillation and treating/preventing venous thromboembolism.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06646328 | FER-CIT-2016-01 2016-004361-12 | Ph 4 | terminated | Oxidative Stress and Circulating Nuclear DNA (cfDNA) in Acute Kidney Injury and Continuous Renal Replacement Therapies. |
| NCT04743011 EnHanCed results posted | UPECLIN-MB-2 | Ph 1, Ph 2 | completed | Enriched Heparin Anti COVID-19 Trial |
| NCT03707418 | IRB00176475 | Ph 1 | withdrawn | Bivalirudin vs Heparin in ECMO Patients |
| NCT02206087 | PER977-01-002 | Ph 1, Ph 2 | completed | Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PER977 Following Heparin |
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.
HEPARIN SODIUM PRESERVATIVE FREE FDA Label Details
Indications & Usage
FDA Label (PDF)Heparin Sodium Injection is indicated for: • Prophylaxis and treatment of venous thrombosis and pulmonary embolism; • Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; • Atrial fibrillation with embolization; • Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); • Prevention of clotting in arterial and cardiac surgery; • Prophylaxis and treatment of peripheral arterial embolism. • Anticoagulant...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.