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LABELS · e8849657-0444-4ca8-bf66-2017f60d5652

ARIMIDEX

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
2026-03-02
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ARIMIDEX is an aromatase inhibitor indicated for: • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 ) • First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer ( 1.2 ) • Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX ( 1.3 ) 1.1 Adjuvant Treatment ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. 1.2 First-Line Treatment ARIMIDEX is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer. 1.3 Second-Line Treatment ARIMIDEX is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.
Full extracted label fields
application numbers
  1. NDA020541
boxed warning exact
    brand names
    1. ARIMIDEX
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=acbfaaa9-503c-4691-9828-76a7146ed6de
    generic names
    1. ANASTROZOLE
    id
    e8849657-0444-4ca8-bf66-2017f60d5652
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ARIMIDEX is an aromatase inhibitor indicated for: • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 ) • First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer ( 1.2 ) • Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX ( 1.3 ) 1.1 Adjuvant Treatment ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. 1.2 First-Line Treatment ARIMIDEX is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer. 1.3 Second-Line Treatment ARIMIDEX is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. ANI Pharmaceuticals, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 62559-670-30
      product ndcs
      1. 62559-670
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 151124
        2. 199224
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00700.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
        700
        total
        830
        sha256
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        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=700&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22e8849657-0444-4ca8-bf66-2017f60d5652%22
        spl effective date
        2026-03-02
        spl effective time
        20260302
        spl set id
        acbfaaa9-503c-4691-9828-76a7146ed6de
        spl version
        12
        substance names
        1. ANASTROZOLE
        uniis
        1. 2Z07MYW1AZ
        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
        Drugs@FDA application source records
        1. application number
          NDA020541
          payload
          all indexed label documents
          1. Appl No
            020541
            Application Docs Date
            2000-09-01 00:00:00
            Application Docs ID
            12698
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          2. Appl No
            020541
            Application Docs Date
            2002-09-05 00:00:00
            Application Docs ID
            12699
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          3. Appl No
            020541
            Application Docs Date
            2005-09-22 00:00:00
            Application Docs ID
            12700
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          4. Appl No
            020541
            Application Docs Date
            2009-01-02 00:00:00
            Application Docs ID
            12701
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            21
            Submission Type
            SUPPL
          5. Appl No
            020541
            Application Docs Date
            2009-05-11 00:00:00
            Application Docs ID
            12702
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            24
            Submission Type
            SUPPL
          6. Appl No
            020541
            Application Docs Date
            2009-05-11 00:00:00
            Application Docs ID
            12703
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            25
            Submission Type
            SUPPL
          7. Appl No
            020541
            Application Docs Date
            2013-05-09 00:00:00
            Application Docs ID
            12704
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            27
            Submission Type
            SUPPL
          8. Appl No
            020541
            Application Docs Date
            2014-05-06 00:00:00
            Application Docs ID
            12705
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            29
            Submission Type
            SUPPL
          9. Appl No
            020541
            Application Docs Date
            2004-09-03 00:00:00
            Application Docs ID
            34802
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          10. Appl No
            020541
            Application Docs Date
            2009-01-02 00:00:00
            Application Docs ID
            34803
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            20
            Submission Type
            SUPPL
          11. Appl No
            020541
            Application Docs Date
            2009-01-02 00:00:00
            Application Docs ID
            34804
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            23
            Submission Type
            SUPPL
          12. Appl No
            020541
            Application Docs Date
            2011-04-18 00:00:00
            Application Docs ID
            34805
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            26
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            020541
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            36
            Submission Status
            AP
            Submission Status Date
            2024-12-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            020541
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            31
            Submission Status
            AP
            Submission Status Date
            2018-12-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            020541
            Review Priority
            Submission Class Code ID
            3
            Submission No
            29
            Submission Status
            AP
            Submission Status Date
            2014-05-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            020541
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            27
            Submission Status
            AP
            Submission Status Date
            2013-05-01 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            020541
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            26
            Submission Status
            AP
            Submission Status Date
            2011-04-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            020541
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2009-04-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            020541
            Review Priority
            UNKNOWN
            Submission Class Code ID
            2
            Submission No
            24
            Submission Status
            AP
            Submission Status Date
            2009-04-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            020541
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            23
            Submission Status
            AP
            Submission Status Date
            2008-12-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            020541
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            21
            Submission Status
            AP
            Submission Status Date
            2008-12-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            020541
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            20
            Submission Status
            AP
            Submission Status Date
            2008-12-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            020541
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            18
            Submission Status
            AP
            Submission Status Date
            2006-05-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            020541
            Review Priority
            UNKNOWN
            Submission Class Code ID
            2
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2005-09-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA020541
          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
          2024-12-16
          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
            020541
            Application Docs Date
            2024-12-17 00:00:00
            Application Docs ID
            80603
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            36
            Submission Type
            SUPPL
          official application record
          Appl No
          020541
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          ANI PHARMS
          openfda application present
          true
          products
          1. Active Ingredient
            ANASTROZOLE
            Appl No
            020541
            Drug Name
            ARIMIDEX
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            1MG
            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 · indication intro context
        application numbers
        1. NDA020541
        brand names
        1. ARIMIDEX
        classification reasons
        1. explicit_positive_indication_predicate
        2. no_tumor_directed_keyword_in_positive_statement
        3. incomplete_colon_led_indication_intro
        clinical review status
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        content role
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        context span
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        true
        exact text
        1 INDICATIONS AND USAGE ARIMIDEX is an aromatase inhibitor indicated for: • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 ) • First-line treatment of postmenopausal women with hormone receptor-positive or hormone recept
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        duplicate text group
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        positive predicate support span
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        is an aromatase inhibitor indicated
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          regulatory links
            schema version
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              1 INDICATIONS AND USAGE ARIMIDEX is an aromatase inhibitor indicated for:
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              spl effective date
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              spl set id
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              structured fields status
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              Source null
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              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
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              Passage 2 · unclassified context
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              1 INDICATIONS AND USAGE ARIMIDEX is an aromatase inhibitor indicated for: • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 ) • First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer ( 1.2 ) • Treatment of advanced breast cancer in
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                  • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 )
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                  1 INDICATIONS AND USAGE ARIMIDEX is an aromatase inhibitor indicated for: • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 ) • First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer ( 1.2 ) • Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamo
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                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            a793380bcf54ef16456e9da6339da5a929ed0b90765c954c25dcb0cdb92ed2aa
                                            start
                                            936
                                            source url
                                            https://api.fda.gov/drug/label.json?search=id%3A%22e8849657-0444-4ca8-bf66-2017f60d5652%22
                                            spl effective date
                                            2026-03-02
                                            spl set id
                                            acbfaaa9-503c-4691-9828-76a7146ed6de
                                            spl version
                                            12
                                            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 9 · unclassified context
                                            application numbers
                                            1. NDA020541
                                            brand names
                                            1. ARIMIDEX
                                            classification reasons
                                            1. no_unambiguous_positive_indication_predicate
                                            clinical review status
                                            pending
                                            content role
                                            unclassified_context
                                            context span
                                            end
                                            1232
                                            end exclusive
                                            true
                                            exact text
                                            or metastatic breast cancer. 1.3 Second-Line Treatment ARIMIDEX is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.
                                            label id
                                            e8849657-0444-4ca8-bf66-2017f60d5652
                                            offset unit
                                            unicode_code_points
                                            source array index
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                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            a793380bcf54ef16456e9da6339da5a929ed0b90765c954c25dcb0cdb92ed2aa
                                            start
                                            906
                                            current approval status
                                            not_reconciled
                                            duplicate text group
                                            dup-8e5d4a11fba5b9e067f2
                                            extraction review status
                                            automated_candidate_pending_source_review
                                            generic names
                                            1. ANASTROZOLE
                                            id
                                            ind-span-8734a38d6696eff8db0c
                                            label id
                                            e8849657-0444-4ca8-bf66-2017f60d5652
                                            positive predicate support span
                                            Source null
                                            qualifier mentions
                                              regulatory links
                                                schema version
                                                0.1.0
                                                source batch sha256
                                                24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                source defined aliases
                                                  source span
                                                  end
                                                  1232
                                                  end exclusive
                                                  true
                                                  exact text
                                                  Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.
                                                  label id
                                                  e8849657-0444-4ca8-bf66-2017f60d5652
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  a793380bcf54ef16456e9da6339da5a929ed0b90765c954c25dcb0cdb92ed2aa
                                                  start
                                                  1106
                                                  source url
                                                  https://api.fda.gov/drug/label.json?search=id%3A%22e8849657-0444-4ca8-bf66-2017f60d5652%22
                                                  spl effective date
                                                  2026-03-02
                                                  spl set id
                                                  acbfaaa9-503c-4691-9828-76a7146ed6de
                                                  spl version
                                                  12
                                                  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