Data updated: May 26, 2026
FARESTON (toremifene citrate)
Oncology
Approved 1997-05-29
1
Indication
--
Phase 3 Trials
28
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1997-05-29
- Routes
- ORAL
- Dosage Forms
- TABLET
FARESTON Approval History
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 1997 to 2024
Jul 2000 SUPPL
Mfg
Dec 1998 SUPPL
Mfg
Nov 1997 SUPPL
Label
May 1997 ORIGINAL
New Drug
What FARESTON Treats
1 FDA approvalsOriginally approved for its first indication in 1997 .
- Other (1)
Other
(1 approval)- • Approved indication (May 1997)
📋
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| NCT03238703 | 9764 NCI-2017-00724, 9764 | Ph 4 | withdrawn | Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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
Track FARESTON with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.