METHOTREXATE PRESERVATIVE FREE (methotrexate sodium) · Fresenius Kabi
METHOTREXATE PRESERVATIVE FREE is FDA-approved to treat 6 conditions (same as METHOTREXATE SODIUM).
Details
- Status
- Prescription
- First Approved
- 1959-08-10
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
METHOTREXATE PRESERVATIVE FREE Approval History
What METHOTREXATE PRESERVATIVE FREE Treats
6 indicationsMETHOTREXATE PRESERVATIVE FREE is approved for 6 conditions since its original approval in 1959. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute lymphoblastic leukemia (ALL)
- Mycosis fungoides (cutaneous T-cell lymphoma)
- Relapsed or refractory non-Hodgkin lymphoma
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis (pJIA)
- Severe psoriasis
Same approved indications as METHOTREXATE SODIUM (same active ingredient).
Fresenius Kabi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02143414 results posted | NCI-2014-01047 NCI-2014-01047, SWOG-S1318 | Ph 2 | active not recruiting | Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia |
| NCT06354439 EcZOL | 77015224.6.1001.5327 | Ph 4 | recruiting | Use of Letrozole for Ectopic Pregnancy |
| NCT05575297 | MRFI | Ph 1 | completed | A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects |
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.
METHOTREXATE PRESERVATIVE FREE FDA Label Details
Indications & Usage
FDA Label (PDF)METHOTREXATE PRESERVATIVE FREE is FDA-approved to treat 6 conditions — same approved indications as METHOTREXATE SODIUM.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.