FARESTON (toremifene citrate) · KYOWA KIRIN
FARESTON is FDA-approved to treat 1 condition (same as TOREMIFENE CITRATE).
Details
- Status
- Discontinued
- First Approved
- 1997-05-29
- Routes
- ORAL
- Dosage Forms
- TABLET
FARESTON Approval History
What FARESTON Treats
1 indicationsFARESTON is approved for 1 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as TOREMIFENE CITRATE (same active ingredient).
KYOWA KIRIN's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03238703 | 9764 NCI-2017-00724, 9764 | Ph 4 | withdrawn | Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer |
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.
FARESTON FDA Label Details
Indications & Usage
FDA Label (PDF)FARESTON is FDA-approved to treat 1 condition — same approved indications as TOREMIFENE CITRATE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.