THIOTEPA
Details
- Status
- Prescription
- First Approved
- 1959-03-09
- Routes
- INJECTION, INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
- Dosage Forms
- INJECTABLE, POWDER
Companies
THIOTEPA Approval History
What THIOTEPA Treats
5 indicationsTHIOTEPA is approved for 5 conditions since its original approval in 1959. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Adenocarcinoma
- Ovarian Adenocarcinoma
- Urinary Bladder Carcinoma
- Lymphoma
- Hodgkin's Lymphoma
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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.
THIOTEPA FDA Label Details
ProIndications & Usage
FDA Label (PDF)Thiotepa for Injection, USP has been tried with varying results in the palliation of a wide variety of neoplastic diseases. However, the most consistent results have been seen in the following tumors: 1. Adenocarcinoma of the breast. 2. Adenocarcinoma of the ovary. 3. For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. 4. For the treatment of superficial papillary carcinoma of the urinary bladder. While now largely superseded by other treatments, thiotepa has been effective against other lymphomas, such as lymphosarcoma and...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.