Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 11857fbe-6c5e-485e-b5d4-7f091a331928

Fareston

Open original source → · Download preserved record

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
2024-11-13
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: QT PROLONGATION FARESTON has been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology (12.2) ] . Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided [see Warnings and Precautions (5.1) ] . WARNING: QT PROLONGATION FARESTON has been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology (12.2) ] . Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided [see Warnings and Precautions (5.1) ] .

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. ( 1 )
Full extracted label fields
application numbers
  1. NDA020497
boxed warning exact
  1. WARNING: QT PROLONGATION FARESTON has been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology (12.2) ] . Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided [see Warnings and Precautions (5.1) ] . WARNING: QT PROLONGATION FARESTON has been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology (12.2) ] . Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided [see Warnings and Precautions (5.1) ] .
brand names
  1. Fareston
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2cab8dd1-3a10-48e6-86ce-0e5275ed49e5
generic names
  1. TOREMIFENE CITRATE
id
11857fbe-6c5e-485e-b5d4-7f091a331928
indications and usage exact
  1. 1 INDICATIONS AND USAGE FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Kyowa Kirin, Inc.
    matched search terms
    1. cancer
    2. tumors
    package ndcs
    1. 42747-327-30
    2. 42747-327-72
    product ndcs
    1. 42747-327
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 152880
      2. 313428
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00000.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      0
      total
      830
      sha256
      0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=0&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%2211857fbe-6c5e-485e-b5d4-7f091a331928%22
      spl effective date
      2024-11-13
      spl effective time
      20241113
      spl set id
      2cab8dd1-3a10-48e6-86ce-0e5275ed49e5
      spl version
      11
      substance names
      1. TOREMIFENE CITRATE
      uniis
      1. 2498Y783QT
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      4. fda_label_posted_after_spl_effective_date_requires_version_review
      Drugs@FDA application source records
      1. application number
        NDA020497
        payload
        all indexed label documents
        1. Appl No
          020497
          Application Docs Date
          2011-03-28 00:00:00
          Application Docs ID
          12638
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        2. Appl No
          020497
          Application Docs Date
          2017-05-15 00:00:00
          Application Docs ID
          48369
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        3. Appl No
          020497
          Application Docs Date
          2024-12-16 00:00:00
          Application Docs ID
          80579
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          020497
          Review Priority
          STANDARD
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          1997-05-29 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          020497
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          1997-11-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          020497
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          1998-12-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          020497
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2000-07-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          020497
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2011-03-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          020497
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2017-05-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          020497
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          2024-12-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA020497
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2024-12-13
        latest label selection rule
        max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
        latest posted label documents
        1. Appl No
          020497
          Application Docs Date
          2024-12-16 00:00:00
          Application Docs ID
          80579
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        official application record
        Appl No
        020497
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        KYOWA KIRIN
        openfda application present
        true
        products
        1. Active Ingredient
          TOREMIFENE CITRATE
          Appl No
          020497
          Drug Name
          FARESTON
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
          marketing status
          1. Discontinued

      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
      application numbers
      1. NDA020497
      brand names
      1. Fareston
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      379
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. ( 1 )
      label id
      11857fbe-6c5e-485e-b5d4-7f091a331928
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      16bf5a18a8448fa0da3d5d88ad7345235ac8254054668dfda78791ce9b10e266
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-4a4d1a78326d6bf91f03
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. TOREMIFENE CITRATE
      id
      ind-span-d26edf51073f61be5ee2
      label id
      11857fbe-6c5e-485e-b5d4-7f091a331928
      positive predicate support span
      end
      77
      end exclusive
      true
      exact text
      is an estrogen agonist/antagonist indicated
      label id
      11857fbe-6c5e-485e-b5d4-7f091a331928
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      16bf5a18a8448fa0da3d5d88ad7345235ac8254054668dfda78791ce9b10e266
      start
      34
      qualifier mentions
      1. context exact
        estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        142
        end exclusive
        true
        exact text
        metastatic breast cancer in postmenopausal
        label id
        11857fbe-6c5e-485e-b5d4-7f091a331928
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        16bf5a18a8448fa0da3d5d88ad7345235ac8254054668dfda78791ce9b10e266
        start
        99
      2. context exact
        estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        144
        end exclusive
        true
        exact text
        metastatic breast cancer in postmenopausal wo
        label id
        11857fbe-6c5e-485e-b5d4-7f091a331928
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        16bf5a18a8448fa0da3d5d88ad7345235ac8254054668dfda78791ce9b10e266
        start
        99
      regulatory links
        schema version
        0.1.0
        source batch sha256
        0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
        source defined aliases
          source span
          end
          198
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
          label id
          11857fbe-6c5e-485e-b5d4-7f091a331928
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          16bf5a18a8448fa0da3d5d88ad7345235ac8254054668dfda78791ce9b10e266
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%2211857fbe-6c5e-485e-b5d4-7f091a331928%22
          spl effective date
          2024-11-13
          spl set id
          2cab8dd1-3a10-48e6-86ce-0e5275ed49e5
          spl version
          11
          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
          Passage 2 · positive indication candidate
          application numbers
          1. NDA020497
          brand names
          1. Fareston
          classification reasons
          1. explicit_positive_indication_predicate
          2. tumor_or_malignant_hematology_words_in_positive_statement
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          379
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. ( 1 )
          label id
          11857fbe-6c5e-485e-b5d4-7f091a331928
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          16bf5a18a8448fa0da3d5d88ad7345235ac8254054668dfda78791ce9b10e266
          start
          0
          current approval status
          not_reconciled
          duplicate text group
          dup-67f94c1aa5af5f62b32c
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. TOREMIFENE CITRATE
          id
          ind-span-af3780f8cf477b5bf05c
          label id
          11857fbe-6c5e-485e-b5d4-7f091a331928
          positive predicate support span
          end
          252
          end exclusive
          true
          exact text
          is an estrogen agonist/antagonist indicated
          label id
          11857fbe-6c5e-485e-b5d4-7f091a331928
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          16bf5a18a8448fa0da3d5d88ad7345235ac8254054668dfda78791ce9b10e266
          start
          209
          qualifier mentions
          1. context exact
            estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            317
            end exclusive
            true
            exact text
            metastatic breast cancer in postmenopausal
            label id
            11857fbe-6c5e-485e-b5d4-7f091a331928
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            16bf5a18a8448fa0da3d5d88ad7345235ac8254054668dfda78791ce9b10e266
            start
            274
          2. context exact
            estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            319
            end exclusive
            true
            exact text
            metastatic breast cancer in postmenopausal wo
            label id
            11857fbe-6c5e-485e-b5d4-7f091a331928
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            16bf5a18a8448fa0da3d5d88ad7345235ac8254054668dfda78791ce9b10e266
            start
            274
          regulatory links
            schema version
            0.1.0
            source batch sha256
            0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
            source defined aliases
              source span
              end
              373
              end exclusive
              true
              exact text
              FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
              label id
              11857fbe-6c5e-485e-b5d4-7f091a331928
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              16bf5a18a8448fa0da3d5d88ad7345235ac8254054668dfda78791ce9b10e266
              start
              199
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%2211857fbe-6c5e-485e-b5d4-7f091a331928%22
              spl effective date
              2024-11-13
              spl set id
              2cab8dd1-3a10-48e6-86ce-0e5275ed49e5
              spl version
              11
              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
              Passage 3 · unclassified context
              application numbers
              1. NDA020497
              brand names
              1. Fareston
              classification reasons
              1. no_unambiguous_positive_indication_predicate
              clinical review status
              pending
              content role
              unclassified_context
              context span
              end
              379
              end exclusive
              true
              exact text
              itive or unknown tumors. FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. ( 1 )
              label id
              11857fbe-6c5e-485e-b5d4-7f091a331928
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              16bf5a18a8448fa0da3d5d88ad7345235ac8254054668dfda78791ce9b10e266
              start
              174
              current approval status
              not_reconciled
              duplicate text group
              dup-eddfb6534239a7789e68
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. TOREMIFENE CITRATE
              id
              ind-span-34f559be2431e6f8988f
              label id
              11857fbe-6c5e-485e-b5d4-7f091a331928
              positive predicate support span
              Source null
              qualifier mentions
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
                  source defined aliases
                    source span
                    end
                    379
                    end exclusive
                    true
                    exact text
                    ( 1 )
                    label id
                    11857fbe-6c5e-485e-b5d4-7f091a331928
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    16bf5a18a8448fa0da3d5d88ad7345235ac8254054668dfda78791ce9b10e266
                    start
                    374
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%2211857fbe-6c5e-485e-b5d4-7f091a331928%22
                    spl effective date
                    2024-11-13
                    spl set id
                    2cab8dd1-3a10-48e6-86ce-0e5275ed49e5
                    spl version
                    11
                    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
                    unclear

                    Preserved source evidence · Not medical advice