FLUTAMIDE
Eulexin capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate. Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin capsules and the goserelin acetate implant should start eight weeks prior to initiating radiation therapy and continue during radiation therapy.
Details
- Status
- Discontinued
- First Approved
- 2001-09-18
- Routes
- ORAL
- Dosage Forms
- CAPSULE
FLUTAMIDE Approval History
What FLUTAMIDE Treats
3 FDA approvalsOriginally approved for its first indication in 2001 . Covers 3 distinct patient populations.
- Other (3)
FLUTAMIDE Boxed Warning
WARNINGS Hepatic Injury There have been postmarketing reports of hospitalization and rarely death due to liver failure in patients taking Eulexin ® . Evidence of hepatic injury included elevated serum transaminase levels, jaundice, hepatic encephalopathy and death related to acute hepatic failure. The hepatic injury was reversible after discontinuation of therapy in some patients. Approximately half of the reported cases occurred within the initial 3 months of treatment with Eulexin ® . Serum tr...
WARNINGS Hepatic Injury There have been postmarketing reports of hospitalization and rarely death due to liver failure in patients taking Eulexin ® . Evidence of hepatic injury included elevated serum transaminase levels, jaundice, hepatic encephalopathy and death related to acute hepatic failure. The hepatic injury was reversible after discontinuation of therapy in some patients. Approximately half of the reported cases occurred within the initial 3 months of treatment with Eulexin ® . Serum transaminase levels should be measured prior to starting treatment with Eulexin ® . Eulexin ® is not recommended in patients whose ALT values exceed twice the upper limit of normal. Serum transaminase levels should then be measured monthly for the first 4 months of therapy, and periodically thereafter. Liver function tests also should be obtained at the first signs and symptoms suggestive of liver dysfunction, e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, "flu-like" symptoms, hyperbilirubinuria, jaundice or right upper quadrant tenderness. If at any time, a patient has jaundice, or their ALT rises above 2 times the upper limit of normal, Eulexin ® should be immediately discontinued with close follow-up of liver function tests until resolution.
Cipla's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03070886 | NRG-GU002 NCI-2016-00963, NRG-GU002 | Ph 2, Ph 3 | completed | Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery |
| NCT05050084 | NRG-GU010 NCI-2021-08760, NRG-GU010 | Ph 3 | active not recruiting | Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial |
| NCT04513717 | NRG-GU009 NCI-2020-04705, NRG-GU009 | Ph 3 | active not recruiting | Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial |
| NCT00936390 results posted | RTOG 0815 CDR0000648194, NCI-2011-01948 | Ph 3 | completed | Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer |
| NCT01786265 | 2012-0993 NCI-2018-01856, 2012-0993 | Ph 2 | active not recruiting | Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer |
| NCT03678025 | S1802 NCI-2018-01738, S1802 | Ph 3 | recruiting | Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer |
| NCT01889199 results posted | UCLA IRB #12-001780 | Ph 2 | completed | Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women |
| NCT02918968 results posted | 9785-MA-3051 | Ph 4 | completed | Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer |
| NCT00651326 DART | PR12 CAN-NCIC-PR12, CDR0000589247 | Ph 3 | terminated | Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer |
| NCT02346578 | OCUU-CRPC | Ph 2 | completed | Comparative Study of Alternative Antiandrogen (AA) Therapy and Early Initiating of Enzalutamide for Castration-resistant Prostate Cancer (CRPC) After Combined Androgen Blockade (CAB) Therapy. |
| NCT00528866 results posted | RTOG-0621 CDR0000563917, NCI-2009-00740 | Ph 2 | completed | Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy |
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.
FLUTAMIDE FDA Label Details
Indications & Usage
Eulexin ® capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate. Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin ® capsules and the goserelin acetate implant should start eight weeks prior to initiating radiation therapy and continue during radiation therapy. Stage D 2 Metastatic Carcinoma To achieve benefit from treatment, Eulexin ® capsules should be initiated with the LHRH-agonist and continued until progression.
WARNINGS Hepatic Injury There have been postmarketing reports of hospitalization and rarely death due to liver failure in patients taking Eulexin ® . Evidence of hepatic injury included elevated serum transaminase levels, jaundice, hepatic encephalopathy and death related to acute hepatic failure. T...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.