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LABELS · 3d1f78f4-d3bd-4778-a610-7d0827dd66c4

Xofigo

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
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. ( 1 )
Full extracted label fields
application numbers
  1. NDA203971
boxed warning exact
    brand names
    1. Xofigo
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a398400e-bd31-41a9-9696-4f7c06569ede
    generic names
    1. RADIUM RA 223 DICHLORIDE
    id
    3d1f78f4-d3bd-4778-a610-7d0827dd66c4
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Bayer HealthCare Pharmaceuticals Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 50419-208-01
      product ndcs
      1. 50419-208
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Embryo-Fetal Toxicity ( 5.3 ) 12/2019
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 1424214
      2. 1424219
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00200.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
      200
      total
      830
      sha256
      d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
      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=200&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%223d1f78f4-d3bd-4778-a610-7d0827dd66c4%22
      spl effective date
      2026-03-02
      spl effective time
      20260302
      spl set id
      a398400e-bd31-41a9-9696-4f7c06569ede
      spl version
      17
      substance names
      1. RADIUM RA-223 DICHLORIDE
      uniis
      1. RJ00KV3VTG
      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
        NDA203971
        payload
        all indexed label documents
        1. Appl No
          203971
          Application Docs Date
          2013-05-15 00:00:00
          Application Docs ID
          19504
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          203971
          Application Docs Date
          2016-03-22 00:00:00
          Application Docs ID
          19505
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        3. Appl No
          203971
          Application Docs Date
          2018-02-02 00:00:00
          Application Docs ID
          52397
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        4. Appl No
          203971
          Application Docs Date
          2018-09-05 00:00:00
          Application Docs ID
          55381
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        5. Appl No
          203971
          Application Docs Date
          2019-12-11 00:00:00
          Application Docs ID
          61241
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          203971
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2013-05-15 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          203971
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2015-02-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          203971
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2015-05-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          203971
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2015-09-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          203971
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2016-03-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          203971
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2016-01-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          203971
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2016-04-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          203971
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2016-05-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          203971
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2018-02-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          203971
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          14
          Submission Status
          AP
          Submission Status Date
          2018-08-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          203971
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2019-12-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA203971
        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
        2019-12-10
        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
          203971
          Application Docs Date
          2019-12-11 00:00:00
          Application Docs ID
          61241
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        official application record
        Appl No
        203971
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        BAYER HLTHCARE
        openfda application present
        true
        products
        1. Active Ingredient
          RADIUM RA-223 DICHLORIDE
          Appl No
          203971
          Drug Name
          XOFIGO
          Form
          SOLUTION;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          162mCi/6ML (27mCi/ML)
          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
      application numbers
      1. NDA203971
      brand names
      1. Xofigo
      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
      386
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral
      label id
      3d1f78f4-d3bd-4778-a610-7d0827dd66c4
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
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      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-70523a4f5b6d9e87a861
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. RADIUM RA 223 DICHLORIDE
      id
      ind-span-3ae1fccdfe1469c89fb3
      label id
      3d1f78f4-d3bd-4778-a610-7d0827dd66c4
      positive predicate support span
      end
      43
      end exclusive
      true
      exact text
      is indicated
      label id
      3d1f78f4-d3bd-4778-a610-7d0827dd66c4
      offset unit
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      source field
      indications_and_usage_exact
      source text sha256
      acc57ef9a9708320b11032fa71a2d30b487d334d4f94bb19c1d6e501b13ccdd2
      start
      31
      qualifier mentions
      1. context exact
        with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        177
        end exclusive
        true
        exact text
        metastases and no known visceral metastatic
        label id
        3d1f78f4-d3bd-4778-a610-7d0827dd66c4
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        acc57ef9a9708320b11032fa71a2d30b487d334d4f94bb19c1d6e501b13ccdd2
        start
        134
      2. context exact
        e cancer, symptomatic bone metastases and no known visceral metastatic disease.
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        185
        end exclusive
        true
        exact text
        metastatic disease
        label id
        3d1f78f4-d3bd-4778-a610-7d0827dd66c4
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        acc57ef9a9708320b11032fa71a2d30b487d334d4f94bb19c1d6e501b13ccdd2
        start
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      regulatory links
        schema version
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        source batch sha256
        d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
        source defined aliases
          source span
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          186
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
          label id
          3d1f78f4-d3bd-4778-a610-7d0827dd66c4
          offset unit
          unicode_code_points
          source array index
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          source field
          indications_and_usage_exact
          source text sha256
          acc57ef9a9708320b11032fa71a2d30b487d334d4f94bb19c1d6e501b13ccdd2
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%223d1f78f4-d3bd-4778-a610-7d0827dd66c4%22
          spl effective date
          2026-03-02
          spl set id
          a398400e-bd31-41a9-9696-4f7c06569ede
          spl version
          17
          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. NDA203971
          brand names
          1. Xofigo
          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
          412
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. ( 1 )
          label id
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          offset unit
          unicode_code_points
          source array index
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          source field
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          source text sha256
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          start
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          current approval status
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          duplicate text group
          dup-ee7295e1c99dce399f04
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. RADIUM RA 223 DICHLORIDE
          id
          ind-span-ac7fcc148637c2b78a06
          label id
          3d1f78f4-d3bd-4778-a610-7d0827dd66c4
          positive predicate support span
          end
          263
          end exclusive
          true
          exact text
          is an alpha particle-emitting radioactive therapeutic agent indicated
          label id
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          offset unit
          unicode_code_points
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          source text sha256
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          start
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          qualifier mentions
          1. context exact
            with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            397
            end exclusive
            true
            exact text
            metastases and no known visceral metastatic
            label id
            3d1f78f4-d3bd-4778-a610-7d0827dd66c4
            offset unit
            unicode_code_points
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            source field
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            source text sha256
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            start
            354
          2. context exact
            e cancer, symptomatic bone metastases and no known visceral metastatic disease.
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            405
            end exclusive
            true
            exact text
            metastatic disease
            label id
            3d1f78f4-d3bd-4778-a610-7d0827dd66c4
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            acc57ef9a9708320b11032fa71a2d30b487d334d4f94bb19c1d6e501b13ccdd2
            start
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          regulatory links
            schema version
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            source batch sha256
            d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
            source defined aliases
              source span
              end
              406
              end exclusive
              true
              exact text
              Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
              label id
              3d1f78f4-d3bd-4778-a610-7d0827dd66c4
              offset unit
              unicode_code_points
              source array index
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              source field
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              source text sha256
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              start
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              source url
              https://api.fda.gov/drug/label.json?search=id%3A%223d1f78f4-d3bd-4778-a610-7d0827dd66c4%22
              spl effective date
              2026-03-02
              spl set id
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              spl version
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              structured fields status
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              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. NDA203971
              brand names
              1. Xofigo
              classification reasons
              1. no_unambiguous_positive_indication_predicate
              clinical review status
              pending
              content role
              unclassified_context
              context span
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              412
              end exclusive
              true
              exact text
              article-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. ( 1 )
              label id
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              offset unit
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              source text sha256
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              current approval status
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              duplicate text group
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              extraction review status
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              generic names
              1. RADIUM RA 223 DICHLORIDE
              id
              ind-span-55fc839f342de0addbe9
              label id
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              positive predicate support span
              Source null
              qualifier mentions
                regulatory links
                  schema version
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                  source defined aliases
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                    end exclusive
                    true
                    exact text
                    ( 1 )
                    label id
                    3d1f78f4-d3bd-4778-a610-7d0827dd66c4
                    offset unit
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                    source array index
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                    source field
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                    source text sha256
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                    start
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                    source url
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                    spl effective date
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                    spl set id
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                    spl version
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                    structured fields status
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                    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