MESNEX
Details
- Status
- Prescription
- First Approved
- 1988-12-30
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- TABLET, INJECTABLE
MESNEX Approval History
What MESNEX Treats
1 indicationsMESNEX is approved for 1 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hemorrhagic Cystitis
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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.
MESNEX FDA Label Details
ProIndications & Usage
FDA Label (PDF)MESNEX is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. MESNEX is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.