DACTINOMYCIN
Details
- Status
- Prescription
- First Approved
- 2010-03-16
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DACTINOMYCIN Approval History
What DACTINOMYCIN Treats
6 indicationsDACTINOMYCIN is approved for 6 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Wilms Tumor
- Rhabdomyosarcoma
- Ewing Sarcoma
- Testicular Cancer
- Gestational Trophoblastic Neoplasia
- Solid Malignancies
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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.
DACTINOMYCIN FDA Label Details
ProIndications & Usage
Dactinomycin for Injection is an actinomycin indicated for the treatment of: adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. post-menarchal patients with gestational trophoblastic...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.