TRANEXAMIC ACID
Details
- Status
- Prescription
- First Approved
- 2011-08-10
- Routes
- INJECTION, INTRAVENOUS, ORAL
- Dosage Forms
- INJECTABLE, SOLUTION, TABLET
Companies
TRANEXAMIC ACID Approval History
What TRANEXAMIC ACID Treats
2 indicationsTRANEXAMIC ACID is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hemophilia
- Hemorrhage
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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.
TRANEXAMIC ACID FDA Label Details
ProIndications & Usage
FDA Label (PDF)Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.