ETOPOSIDE
Details
- Status
- Prescription
- First Approved
- 1994-02-10
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, CAPSULE
Companies
ETOPOSIDE Approval History
What ETOPOSIDE Treats
2 indicationsETOPOSIDE is approved for 2 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Testicular Cancer
- Small Cell Lung Cancer
ETOPOSIDE Boxed Warning
WARNINGS Etoposide injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur....
WARNINGS Etoposide injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur.
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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.
ETOPOSIDE FDA Label Details
ProIndications & Usage
Etoposide Injection is indicated in the management of the following neoplasms: Refractory Testicular Tumors Etoposide Injection in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. Small Cell Lung Cancer Etoposide Injection and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
WARNINGS Etoposide injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.