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

LABELS · 2f9c7d6f-7f0f-f9dd-e063-6294a90abf59

Axumin

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
2025-03-05
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment ( 1 ).
Full extracted label fields
application numbers
  1. NDA208054
boxed warning exact
    brand names
    1. Axumin
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=389a502e-a7d5-43dd-b6bf-f022ff23f3b9
    generic names
    1. FLUCICLOVINE F-18
    id
    2f9c7d6f-7f0f-f9dd-e063-6294a90abf59
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment ( 1 ).
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Blue Earth Diagnostics
      matched search terms
      1. cancer
      package ndcs
      1. 69932-001-30
      2. 69932-001-50
      product ndcs
      1. 69932-001
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
          source batch
          file
          /private/tmp/cancer-full-research/indications/raw/labels-00100.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
          100
          total
          830
          sha256
          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
          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=100&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%222f9c7d6f-7f0f-f9dd-e063-6294a90abf59%22
          spl effective date
          2025-03-05
          spl effective time
          20250305
          spl set id
          389a502e-a7d5-43dd-b6bf-f022ff23f3b9
          spl version
          16
          substance names
          1. FLUCICLOVINE F-18
          uniis
          1. 38R1Q0L1ZE
          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
            NDA208054
            payload
            all indexed label documents
            1. Appl No
              208054
              Application Docs Date
              2016-05-27 00:00:00
              Application Docs ID
              40615
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              ORIG
            2. Appl No
              208054
              Application Docs Date
              2021-05-24 00:00:00
              Application Docs ID
              67579
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              34
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              208054
              Review Priority
              PRIORITY
              Submission Class Code ID
              7
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2016-05-27 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            2. Appl No
              208054
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              2
              Submission Status
              AP
              Submission Status Date
              2016-12-19 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              208054
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              3
              Submission Status
              AP
              Submission Status Date
              2017-01-24 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              208054
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              34
              Submission Status
              AP
              Submission Status Date
              2021-05-21 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA208054
            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
            2021-05-21
            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
              208054
              Application Docs Date
              2021-05-24 00:00:00
              Application Docs ID
              67579
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              34
              Submission Type
              SUPPL
            official application record
            Appl No
            208054
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            BLUE EARTH
            openfda application present
            true
            products
            1. Active Ingredient
              FLUCICLOVINE F-18
              Appl No
              208054
              Drug Name
              AXUMIN
              Form
              SOLUTION;INTRAVENOUS
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              9-221mCi/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. NDA208054
          brand names
          1. Axumin
          classification reasons
          1. explicit_positive_indication_predicate
          2. diagnostic_use_words
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          421
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (P
          label id
          2f9c7d6f-7f0f-f9dd-e063-6294a90abf59
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          057c896eaabd52e22357b1453db008966be9ad422f667dff4fc04a842f7c4a25
          start
          0
          current approval status
          not_reconciled
          duplicate text group
          dup-c48aacec879368a2c1e8
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. FLUCICLOVINE F-18
          id
          ind-span-ddc225d9d39489fde9af
          label id
          2f9c7d6f-7f0f-f9dd-e063-6294a90abf59
          positive predicate support span
          end
          43
          end exclusive
          true
          exact text
          is indicated
          label id
          2f9c7d6f-7f0f-f9dd-e063-6294a90abf59
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          057c896eaabd52e22357b1453db008966be9ad422f667dff4fc04a842f7c4a25
          start
          31
          qualifier mentions
          1. context exact
            ated blood prostate specific antigen (PSA) levels following prior treatment.
            kind
            prior_therapy_or_line
            polarity
            not_inferred
            span
            end
            220
            end exclusive
            true
            exact text
            prior treatment
            label id
            2f9c7d6f-7f0f-f9dd-e063-6294a90abf59
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            057c896eaabd52e22357b1453db008966be9ad422f667dff4fc04a842f7c4a25
            start
            205
          regulatory links
            schema version
            0.1.0
            source batch sha256
            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
            source defined aliases
              source span
              end
              221
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
              label id
              2f9c7d6f-7f0f-f9dd-e063-6294a90abf59
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              057c896eaabd52e22357b1453db008966be9ad422f667dff4fc04a842f7c4a25
              start
              0
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%222f9c7d6f-7f0f-f9dd-e063-6294a90abf59%22
              spl effective date
              2025-03-05
              spl set id
              389a502e-a7d5-43dd-b6bf-f022ff23f3b9
              spl version
              16
              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
              diagnostic_candidate
              Passage 2 · positive indication candidate
              application numbers
              1. NDA208054
              brand names
              1. Axumin
              classification reasons
              1. explicit_positive_indication_predicate
              2. diagnostic_use_words
              clinical review status
              pending
              content role
              positive_indication_candidate
              context span
              end
              464
              end exclusive
              true
              exact text
              E Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment ( 1 ).
              label id
              2f9c7d6f-7f0f-f9dd-e063-6294a90abf59
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              057c896eaabd52e22357b1453db008966be9ad422f667dff4fc04a842f7c4a25
              start
              22
              current approval status
              not_reconciled
              duplicate text group
              dup-9169c41b0fe44b333dae
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. FLUCICLOVINE F-18
              id
              ind-span-93e3f3d56878e1664015
              label id
              2f9c7d6f-7f0f-f9dd-e063-6294a90abf59
              positive predicate support span
              end
              272
              end exclusive
              true
              exact text
              is a radioactive diagnostic agent indicated
              label id
              2f9c7d6f-7f0f-f9dd-e063-6294a90abf59
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              057c896eaabd52e22357b1453db008966be9ad422f667dff4fc04a842f7c4a25
              start
              229
              qualifier mentions
              1. context exact
                ated blood prostate specific antigen (PSA) levels following prior treatment ( 1 ).
                kind
                prior_therapy_or_line
                polarity
                not_inferred
                span
                end
                463
                end exclusive
                true
                exact text
                prior treatment ( 1 )
                label id
                2f9c7d6f-7f0f-f9dd-e063-6294a90abf59
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                057c896eaabd52e22357b1453db008966be9ad422f667dff4fc04a842f7c4a25
                start
                442
              regulatory links
                schema version
                0.1.0
                source batch sha256
                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                source defined aliases
                  source span
                  end
                  464
                  end exclusive
                  true
                  exact text
                  Axumin is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment ( 1 ).
                  label id
                  2f9c7d6f-7f0f-f9dd-e063-6294a90abf59
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  057c896eaabd52e22357b1453db008966be9ad422f667dff4fc04a842f7c4a25
                  start
                  222
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%222f9c7d6f-7f0f-f9dd-e063-6294a90abf59%22
                  spl effective date
                  2025-03-05
                  spl set id
                  389a502e-a7d5-43dd-b6bf-f022ff23f3b9
                  spl version
                  16
                  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
                  diagnostic_candidate

                  Preserved source evidence · Not medical advice