OXSORALEN-ULTRA
Details
- Status
- Prescription
- First Approved
- 1986-10-30
- Routes
- ORAL
- Dosage Forms
- CAPSULE
OXSORALEN-ULTRA Approval History
What OXSORALEN-ULTRA Treats
1 indicationsOXSORALEN-ULTRA is approved for 1 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cutaneous T-Cell Lymphoma
OXSORALEN-ULTRA Boxed Warning
UVADEX ® (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS ® CELLEX ® Photopheresis System. Please consult the CELLEX ® Operator's Manual before using this product....
UVADEX ® (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS ® CELLEX ® Photopheresis System. Please consult the CELLEX ® Operator's Manual before using this product.
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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.
OXSORALEN-ULTRA FDA Label Details
ProIndications & Usage
FDA Label (PDF)UVADEX ® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS ® CELLEX ® Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.
UVADEX ® (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS ® CELLEX ® Photopheresis System. Please consult the CELLEX ® Operator's Manua...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.