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LABELS · 6aeb23c4-3f3f-4966-829c-12e7e6ec91ef

EXEMESTANE

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
2025-12-24
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE EXEMESTANE is an aromatase inhibitor indicated for: • adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ). • treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). 1.1 Adjuvant Treatment of Postmenopausal Women EXEMESTANE is indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1) ]. 1.2 Advanced Breast Cancer in Postmenopausal Women EXEMESTANE is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2) ].
Full extracted label fields
application numbers
  1. NDA020753
boxed warning exact
    brand names
    1. EXEMESTANE
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=69abd0ff-b200-4d1a-b14a-80e980a8e781
    generic names
    1. EXEMESTANE
    id
    6aeb23c4-3f3f-4966-829c-12e7e6ec91ef
    indications and usage exact
    1. 1 INDICATIONS AND USAGE EXEMESTANE is an aromatase inhibitor indicated for: • adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ). • treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). 1.1 Adjuvant Treatment of Postmenopausal Women EXEMESTANE is indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1) ]. 1.2 Advanced Breast Cancer in Postmenopausal Women EXEMESTANE is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2) ].
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Mylan Pharmaceuticals Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 59762-2858-1
      product ndcs
      1. 59762-2858
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
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        routes
        1. ORAL
        rxcuis
        1. 310261
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00400.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
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        sha256
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        url
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        source url
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        spl effective date
        2025-12-24
        spl effective time
        20251224
        spl set id
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        spl version
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        substance names
        1. EXEMESTANE
        uniis
        1. NY22HMQ4BX
        verification flags
        1. oncology_keyword_candidate_not_clinically_classified
        2. spl_text_not_verified_identical_to_latest_approved_label
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        Drugs@FDA application source records
        1. application number
          NDA020753
          payload
          all indexed label documents
          1. Appl No
            020753
            Application Docs Date
            1999-10-21 00:00:00
            Application Docs ID
            13341
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            020753
            Application Docs Date
            2003-12-02 00:00:00
            Application Docs ID
            13342
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          3. Appl No
            020753
            Application Docs Date
            2004-09-29 00:00:00
            Application Docs ID
            13343
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          4. Appl No
            020753
            Application Docs Date
            2005-10-07 00:00:00
            Application Docs ID
            13344
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          5. Appl No
            020753
            Application Docs Date
            2011-03-28 00:00:00
            Application Docs ID
            13345
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          6. Appl No
            020753
            Application Docs Date
            2011-03-28 00:00:00
            Application Docs ID
            13346
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          7. Appl No
            020753
            Application Docs Date
            2011-03-28 00:00:00
            Application Docs ID
            13347
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          8. Appl No
            020753
            Application Docs Date
            2013-02-20 00:00:00
            Application Docs ID
            13348
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            14
            Submission Type
            SUPPL
          9. Appl No
            020753
            Application Docs Date
            2014-05-06 00:00:00
            Application Docs ID
            13349
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          10. Appl No
            020753
            Application Docs Date
            2016-07-27 00:00:00
            Application Docs ID
            13350
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            18
            Submission Type
            SUPPL
          11. Appl No
            020753
            Application Docs Date
            2014-05-06 00:00:00
            Application Docs ID
            35273
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          12. Appl No
            020753
            Application Docs Date
            2018-05-22 00:00:00
            Application Docs ID
            54284
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            20
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            020753
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2024-12-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            020753
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            22
            Submission Status
            AP
            Submission Status Date
            2021-11-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            020753
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            20
            Submission Status
            AP
            Submission Status Date
            2018-05-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            020753
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            18
            Submission Status
            AP
            Submission Status Date
            2016-07-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            020753
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2014-07-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            020753
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2014-05-02 00:00:00
            Submission Type
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            Submissions Public Notes
          7. Appl No
            020753
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2014-05-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            020753
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            14
            Submission Status
            AP
            Submission Status Date
            2013-02-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            020753
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            12
            Submission Status
            AP
            Submission Status Date
            2011-03-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            020753
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2011-03-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            020753
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2011-03-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            020753
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2008-12-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA020753
          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
            020753
            Application Docs Date
            2024-12-17 00:00:00
            Application Docs ID
            80601
            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
            25
            Submission Type
            SUPPL
          official application record
          Appl No
          020753
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          PFIZER
          openfda application present
          true
          products
          1. Active Ingredient
            EXEMESTANE
            Appl No
            020753
            Drug Name
            AROMASIN
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            25MG
            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. NDA020753
        brand names
        1. EXEMESTANE
        classification reasons
        1. explicit_positive_indication_predicate
        2. no_tumor_directed_keyword_in_positive_statement
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        clinical review status
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        content role
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        true
        exact text
        1 INDICATIONS AND USAGE EXEMESTANE is an aromatase inhibitor indicated for: • adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a t
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        is an aromatase inhibitor indicated
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              1 INDICATIONS AND USAGE EXEMESTANE is an aromatase inhibitor indicated for:
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              1 INDICATIONS AND USAGE EXEMESTANE is an aromatase inhibitor indicated for: • adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ). • treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). 1.1 Adjuvant Treatment of Postmenopausal Women EXEMESTANE is indicated
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                l women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ).
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                  • adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ).
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                  ositive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ). • treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). 1.1 Adjuvant Treatment of Postmenopausal Women EXEMESTANE is indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to thre
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