TAMOXIFEN CITRATE
Details
- Status
- Prescription
- First Approved
- 2003-02-20
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
TAMOXIFEN CITRATE Approval History
What TAMOXIFEN CITRATE Treats
3 indicationsTAMOXIFEN CITRATE is approved for 3 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic Breast Cancer
- Breast Cancer
- Ductal Carcinoma In Situ
TAMOXIFEN CITRATE Boxed Warning
WARNING For Women With Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies , Reduction in Breast Cancer Incidence in High Risk Women ). Uterine malignancies...
WARNING For Women With Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies , Reduction in Breast Cancer Incidence in High Risk Women ). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for tamoxifen vs. 0.4 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for tamoxifen vs. 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for tamoxifen versus 0.25 for placebo**. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen citrate outweigh its risks in women already diagnosed with breast cancer. *Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See WARNINGS: Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma . **See Table 3 under CLINICAL PHARMACOLOGY, Clinical Studies .
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Active Pipeline
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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.
TAMOXIFEN CITRATE FDA Label Details
ProIndications & Usage
Metastatic Breast Cancer: Tamoxifen citrate tablets, USP are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. Adjuvant Treatment of Breast Cancer: Tamoxifen citrate tablets, USP are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary disse...
WARNING For Women With Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.