VINCRISTINE SULFATE PFS
Details
- Status
- Prescription
- First Approved
- 1988-04-19
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VINCRISTINE SULFATE PFS Approval History
What VINCRISTINE SULFATE PFS Treats
6 indicationsVINCRISTINE SULFATE PFS is approved for 6 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Leukemia
- Hodgkin's Disease
- Non-Hodgkin's Lymphoma
- Rhabdomyosarcoma
- Neuroblastoma
- Wilms' Tumor
VINCRISTINE SULFATE PFS Boxed Warning
WARNINGS Caution–This preparation should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of Vincristine Sulfate Injection may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion ...
WARNINGS Caution–This preparation should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of Vincristine Sulfate Injection may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis. FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES. See OVERDOSAGE section for the treatment of patients given intrathecal Vincristine Sulfate Injection.
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Active Pipeline
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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.
VINCRISTINE SULFATE PFS FDA Label Details
ProIndications & Usage
FDA Label (PDF)Vincristine Sulfate Injection is indicated in acute leukemia. Vincristine Sulfate Injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non–Hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor.
WARNINGS Caution–This preparation should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue dur...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.