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LABELS · 5bcbc281-342c-4b05-8409-53a08b1fc9f6

SOLTAMOX

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2021-11-29
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS Serious and life-threatening events from the use of SOLTAMOX include uterine malignancies, stroke, and pulmonary embolism [see Warnings and Precautions (5.1 , 5.2) ] . Fatal cases of each type of event have occurred. Incidence rates per 1000 women-years for these events were estimated from the National Surgical Adjuvant Breast and Bowel Project (NSABP) P-1 trial in women at high risk for breast cancer [see Clinical Studies (14.4) ] : Endometrial adenocarcinoma: 2.20 for tamoxifen vs. 0.71 for placebo Uterine sarcoma: 0.17 for tamoxifen vs. 0.04 for placebo Stroke: 1.43 for tamoxifen vs. 1.00 for placebo. Pulmonary embolism: 0.75 for tamoxifen versus 0.25 for placebo. Discuss the potential benefits of tamoxifen versus the potential risks of these serious events with women at high risk for breast cancer and women with ductal carcinoma in situ (DCIS) considering tamoxifen to reduce the risk of developing breast cancer [see Warnings and Precautions (5) ]. For most patients already diagnosed with breast cancer, the benefits of tamoxifen outweigh its risks. WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS See full prescribing information for complete boxed warning . Serious, life-threatening, and fatal events from use of tamoxifen include uterine malignancies, stroke, and pulmonary embolism. ( 5.1 , 5.2 ) Discuss risks and benefits of tamoxifen with women at high risk for breast cancer and women with ductal carcinoma in situ (DCIS) when considering tamoxifen use to reduce the risk of developing breast cancer. ( 5.1 , 5.2 ) For most patients already diagnosed with breast cancer, the benefits of tamoxifen outweigh its risks. ( 5.1 , 5.2 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE SOLTAMOX is an estrogen agonist/antagonist indicated: For treatment of adult patients with estrogen receptor-positive metastatic breast cancer ( 1.1 ) For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer ( 1.2 ) To reduce risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS) ( 1.3 ) To reduce the incidence of breast cancer in adult women at high risk ( 1.4 ) 1.1 Metastatic Breast Cancer SOLTAMOX is indicated for the treatment of adult patients with estrogen receptor-positive metastatic breast cancer. 1.2 Adjuvant Treatment of Breast Cancer SOLTAMOX is indicated: for the adjuvant treatment of adult patients with early stage estrogen receptor-positive breast cancer to reduce the occurrence of contralateral breast cancer in adult patients when used as adjuvant therapy for the treatment of breast cancer. 1.3 Ductal Carcinoma in Situ In adult women with DCIS, following breast surgery and radiation, SOLTAMOX is indicated to reduce the risk of invasive breast cancer [see Boxed Warning and Clinical Studies (14.3) ] . 1.4 Reduction in Breast Cancer Incidence in Women at High Risk SOLTAMOX is indicated to reduce the incidence of breast cancer in adult women at high risk for breast cancer. [see Boxed Warning and Clinical Studies (14.4) ] .
Full extracted label fields
application numbers
  1. NDA021807
boxed warning exact
  1. WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS Serious and life-threatening events from the use of SOLTAMOX include uterine malignancies, stroke, and pulmonary embolism [see Warnings and Precautions (5.1 , 5.2) ] . Fatal cases of each type of event have occurred. Incidence rates per 1000 women-years for these events were estimated from the National Surgical Adjuvant Breast and Bowel Project (NSABP) P-1 trial in women at high risk for breast cancer [see Clinical Studies (14.4) ] : Endometrial adenocarcinoma: 2.20 for tamoxifen vs. 0.71 for placebo Uterine sarcoma: 0.17 for tamoxifen vs. 0.04 for placebo Stroke: 1.43 for tamoxifen vs. 1.00 for placebo. Pulmonary embolism: 0.75 for tamoxifen versus 0.25 for placebo. Discuss the potential benefits of tamoxifen versus the potential risks of these serious events with women at high risk for breast cancer and women with ductal carcinoma in situ (DCIS) considering tamoxifen to reduce the risk of developing breast cancer [see Warnings and Precautions (5) ]. For most patients already diagnosed with breast cancer, the benefits of tamoxifen outweigh its risks. WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS See full prescribing information for complete boxed warning . Serious, life-threatening, and fatal events from use of tamoxifen include uterine malignancies, stroke, and pulmonary embolism. ( 5.1 , 5.2 ) Discuss risks and benefits of tamoxifen with women at high risk for breast cancer and women with ductal carcinoma in situ (DCIS) when considering tamoxifen use to reduce the risk of developing breast cancer. ( 5.1 , 5.2 ) For most patients already diagnosed with breast cancer, the benefits of tamoxifen outweigh its risks. ( 5.1 , 5.2 )
brand names
  1. SOLTAMOX
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e6ff055-590c-41e6-9530-1fdf04cdbd02
generic names
  1. TAMOXIFEN CITRATE
id
5bcbc281-342c-4b05-8409-53a08b1fc9f6
indications and usage exact
  1. 1 INDICATIONS AND USAGE SOLTAMOX is an estrogen agonist/antagonist indicated: For treatment of adult patients with estrogen receptor-positive metastatic breast cancer ( 1.1 ) For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer ( 1.2 ) To reduce risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS) ( 1.3 ) To reduce the incidence of breast cancer in adult women at high risk ( 1.4 ) 1.1 Metastatic Breast Cancer SOLTAMOX is indicated for the treatment of adult patients with estrogen receptor-positive metastatic breast cancer. 1.2 Adjuvant Treatment of Breast Cancer SOLTAMOX is indicated: for the adjuvant treatment of adult patients with early stage estrogen receptor-positive breast cancer to reduce the occurrence of contralateral breast cancer in adult patients when used as adjuvant therapy for the treatment of breast cancer. 1.3 Ductal Carcinoma in Situ In adult women with DCIS, following breast surgery and radiation, SOLTAMOX is indicated to reduce the risk of invasive breast cancer [see Boxed Warning and Clinical Studies (14.3) ] . 1.4 Reduction in Breast Cancer Incidence in Women at High Risk SOLTAMOX is indicated to reduce the incidence of breast cancer in adult women at high risk for breast cancer. [see Boxed Warning and Clinical Studies (14.4) ] .
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Mayne Pharma
    matched search terms
    1. cancer
    2. carcinoma
    package ndcs
    1. 51862-682-01
    2. 51862-682-00
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    1. 51862-682
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      last updated
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      1. TAMOXIFEN CITRATE
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      1. application number
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        payload
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        5. Appl No
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          Review Priority
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          Submission Status Date
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        approval interpretation
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          Application Docs ID
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        Appl No
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        Sponsor Name
        MAYNE PHARMA COMMRCL
        openfda application present
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        products
        1. Active Ingredient
          TAMOXIFEN CITRATE
          Appl No
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          Drug Name
          SOLTAMOX
          Form
          SOLUTION;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 20MG BASE/10ML
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
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      1 INDICATIONS AND USAGE SOLTAMOX is an estrogen agonist/antagonist indicated: For treatment of adult patients with estrogen receptor-positive metastatic breast cancer ( 1.1 ) For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer ( 1.2 ) To reduce risk of invasive breast cancer following breast surgery and radiation in adult wo
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          1 INDICATIONS AND USAGE SOLTAMOX is an estrogen agonist/antagonist indicated: For treatment of adult patients with estrogen receptor-positive metastatic breast cancer ( 1.1 )
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          1 INDICATIONS AND USAGE SOLTAMOX is an estrogen agonist/antagonist indicated: For treatment of adult patients with estrogen receptor-positive metastatic breast cancer ( 1.1 ) For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer ( 1.2 ) To reduce risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS) ( 1.3 ) To reduce the incidence of breast cancer in adult women at
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              reatment of adult patients with estrogen receptor-positive metastatic breast cancer ( 1.1 ) For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer ( 1.2 ) To reduce risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS) ( 1.3 ) To reduce the incidence of breast cancer in adult women at high risk ( 1.4 ) 1.1 Metastatic Breast Cancer SOLTAMOX is indicated for the treatment of adult patients with estrogen receptor-positive met
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                ive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS) ( 1.3 )
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                                  Source null
                                  approval pathway
                                  Source null
                                  biomarker and test
                                  Source null
                                  disease stage
                                  Source null
                                  limitations
                                  Source null
                                  line
                                  Source null
                                  prior therapy
                                  Source null
                                  regimen
                                  Source null
                                  tumor histology
                                  Source null
                                  use intent
                                  tumor_directed_candidate
                                  Passage 8 · positive indication candidate
                                  application numbers
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                                  brand names
                                  1. SOLTAMOX
                                  classification reasons
                                  1. explicit_positive_indication_predicate
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                                  rcinoma in Situ In adult women with DCIS, following breast surgery and radiation, SOLTAMOX is indicated to reduce the risk of invasive breast cancer [see Boxed Warning and Clinical Studies (14.3) ] . 1.4 Reduction in Breast Cancer Incidence in Women at High Risk SOLTAMOX is indicated to reduce the incidence of breast cancer in adult women at high risk for breast cancer. [see Boxed Warning and Clinical Studies (14.4) ] .
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                                  duplicate text group
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                                  1. TAMOXIFEN CITRATE
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                                  qualifier mentions
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                                    OX is indicated to reduce the incidence of breast cancer in adult women at high risk for breast cancer. [see Boxed Warning an
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                                  regulatory links
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                                    source defined aliases
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                                      1387
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                                      exact text
                                      1.4 Reduction in Breast Cancer Incidence in Women at High Risk SOLTAMOX is indicated to reduce the incidence of breast cancer in adult women at high risk for breast cancer. [see Boxed Warning and Clinical Studies (14.4) ] .
                                      label id
                                      5bcbc281-342c-4b05-8409-53a08b1fc9f6
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                                      source url
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                                      spl effective date
                                      2021-11-29
                                      spl set id
                                      1e6ff055-590c-41e6-9530-1fdf04cdbd02
                                      spl version
                                      2
                                      structured fields status
                                      not_extracted_no_values_inferred_from_mentions
                                      structured indication
                                      age
                                      Source null
                                      approval pathway
                                      Source null
                                      biomarker and test
                                      Source null
                                      disease stage
                                      Source null
                                      limitations
                                      Source null
                                      line
                                      Source null
                                      prior therapy
                                      Source null
                                      regimen
                                      Source null
                                      tumor histology
                                      Source null
                                      use intent
                                      tumor_directed_candidate

                                      Preserved source evidence · Not medical advice