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

LABELS · 44cadee9-19ca-4756-ab85-0836b38db89f

AdreView

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2024-01-10
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 AdreView is a radiopharmaceutical agent for gamma-scintigraphy indicated for: use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests ( 1.1 ) scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6. ( 1.2 ) Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for: selecting a therapeutic intervention or for monitoring the response to therapy; using the H/M ratio to identify a patient with a high risk for death. 1.1 Pheochromocytoma and Neuroblastoma AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. 1.2 Congestive Heart Failure AdreView is indicated for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6. Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for: selecting a therapeutic intervention or for monitoring the response to therapy; using the H/M ratio to identify a patient with a high risk for death.
Full extracted label fields
application numbers
  1. NDA022290
boxed warning exact
    brand names
    1. AdreView
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c89d3ecc-4f4c-4566-8808-79152344194d
    generic names
    1. IOBENGUANE I-123
    id
    44cadee9-19ca-4756-ab85-0836b38db89f
    indications and usage exact
    1. 1 INDICATIONS AND USAGE AdreView is a radiopharmaceutical agent for gamma-scintigraphy indicated for: use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests ( 1.1 ) scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6. ( 1.2 ) Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for: selecting a therapeutic intervention or for monitoring the response to therapy; using the H/M ratio to identify a patient with a high risk for death. 1.1 Pheochromocytoma and Neuroblastoma AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. 1.2 Congestive Heart Failure AdreView is indicated for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6. Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for: selecting a therapeutic intervention or for monitoring the response to therapy; using the H/M ratio to identify a patient with a high risk for death.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Medi-Physics Inc.
      matched search terms
      1. neuroblastoma
      2. pheochromocytoma
      package ndcs
      1. 17156-235-01
      product ndcs
      1. 17156-235
      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-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%2244cadee9-19ca-4756-ab85-0836b38db89f%22
          spl effective date
          2024-01-10
          spl effective time
          20240110
          spl set id
          c89d3ecc-4f4c-4566-8808-79152344194d
          spl version
          9
          substance names
          1. IOBENGUANE I-123
          uniis
          1. P2TH1XYZ84
          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
            NDA022290
            payload
            all indexed label documents
            1. Appl No
              022290
              Application Docs Date
              2008-09-19 00:00:00
              Application Docs ID
              38517
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              ORIG
            2. Appl No
              022290
              Application Docs Date
              2013-03-26 00:00:00
              Application Docs ID
              38518
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              SUPPL
            3. Appl No
              022290
              Application Docs Date
              2020-03-06 00:00:00
              Application Docs ID
              62069
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              5
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              022290
              Review Priority
              PRIORITY
              Submission Class Code ID
              7
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2008-09-19 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            2. Appl No
              022290
              Review Priority
              STANDARD
              Submission Class Code ID
              2
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2013-03-20 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              022290
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              4
              Submission Status
              AP
              Submission Status Date
              2016-06-06 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              022290
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              5
              Submission Status
              AP
              Submission Status Date
              2020-03-05 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA022290
            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
            2020-03-05
            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
              022290
              Application Docs Date
              2020-03-06 00:00:00
              Application Docs ID
              62069
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              5
              Submission Type
              SUPPL
            official application record
            Appl No
            022290
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            GE HEALTHCARE
            openfda application present
            true
            products
            1. Active Ingredient
              IOBENGUANE SULFATE I-123
              Appl No
              022290
              Drug Name
              ADREVIEW
              Form
              SOLUTION;INTRAVENOUS
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              10mCi/5ML (2mCi/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. NDA022290
          brand names
          1. AdreView
          classification reasons
          1. explicit_positive_indication_predicate
          2. diagnostic_use_words
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          718
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE AdreView is a radiopharmaceutical agent for gamma-scintigraphy indicated for: use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests ( 1.1 ) scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6. ( 1.2 ) Limitations of Use: In patients with cong
          label id
          44cadee9-19ca-4756-ab85-0836b38db89f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
          start
          0
          current approval status
          not_reconciled
          duplicate text group
          dup-3ccffe0f103a46595da7
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. IOBENGUANE I-123
          id
          ind-span-380c6d6fb426973e2755
          label id
          44cadee9-19ca-4756-ab85-0836b38db89f
          positive predicate support span
          end
          96
          end exclusive
          true
          exact text
          is a radiopharmaceutical agent for gamma-scintigraphy indicated
          label id
          44cadee9-19ca-4756-ab85-0836b38db89f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
          start
          33
          qualifier mentions
          1. context exact
            ntigraphy indicated for: use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests ( 1.1 ) scintigrap
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            180
            end exclusive
            true
            exact text
            metastatic pheochromocytoma or neuroblastom
            label id
            44cadee9-19ca-4756-ab85-0836b38db89f
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
            start
            137
          2. context exact
            ntigraphy indicated for: use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests ( 1.1 ) scintigraphi
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            182
            end exclusive
            true
            exact text
            metastatic pheochromocytoma or neuroblastoma
            label id
            44cadee9-19ca-4756-ab85-0836b38db89f
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
            start
            137
          regulatory links
            schema version
            0.1.0
            source batch sha256
            d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
            source defined aliases
              source span
              end
              518
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE AdreView is a radiopharmaceutical agent for gamma-scintigraphy indicated for: use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests ( 1.1 ) scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%.
              label id
              44cadee9-19ca-4756-ab85-0836b38db89f
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
              start
              0
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%2244cadee9-19ca-4756-ab85-0836b38db89f%22
              spl effective date
              2024-01-10
              spl set id
              c89d3ecc-4f4c-4566-8808-79152344194d
              spl version
              9
              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. NDA022290
              brand names
              1. AdreView
              classification reasons
              1. inherited_predicate_from_same_label_section_requires_review
              2. no_tumor_directed_keyword_in_positive_statement
              clinical review status
              pending
              content role
              positive_indication_candidate
              context span
              end
              868
              end exclusive
              true
              exact text
              he heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6. ( 1.2 ) Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for: selecting a therapeutic intervention or for monitoring the response to therapy; u
              label id
              44cadee9-19ca-4756-ab85-0836b38db89f
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
              start
              319
              current approval status
              not_reconciled
              duplicate text group
              dup-bec80907eaf9260e292e
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. IOBENGUANE I-123
              id
              ind-span-604229c4e416ee2f8c0a
              label id
              44cadee9-19ca-4756-ab85-0836b38db89f
              positive predicate support span
              end
              96
              end exclusive
              true
              exact text
              is a radiopharmaceutical agent for gamma-scintigraphy indicated
              label id
              44cadee9-19ca-4756-ab85-0836b38db89f
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
              start
              33
              qualifier mentions
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                  source defined aliases
                    source span
                    end
                    668
                    end exclusive
                    true
                    exact text
                    Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6.
                    label id
                    44cadee9-19ca-4756-ab85-0836b38db89f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                    start
                    519
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%2244cadee9-19ca-4756-ab85-0836b38db89f%22
                    spl effective date
                    2024-01-10
                    spl set id
                    c89d3ecc-4f4c-4566-8808-79152344194d
                    spl version
                    9
                    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
                    non_oncology_or_unclear_candidate
                    Passage 3 · limitation of use
                    application numbers
                    1. NDA022290
                    brand names
                    1. AdreView
                    classification reasons
                    1. negative_or_not_established_clause
                    clinical review status
                    pending
                    content role
                    limitation_of_use
                    context span
                    end
                    1136
                    end exclusive
                    true
                    exact text
                    left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6. ( 1.2 ) Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for: selecting a therapeutic intervention or for monitoring the response to therapy; using the H/M ratio to identify a patient with a high risk for death. 1.1 Pheochromocytoma and Neuroblastoma AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnosti
                    label id
                    44cadee9-19ca-4756-ab85-0836b38db89f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                    start
                    469
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-8ba40bb8e82c4c16e76b
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. IOBENGUANE I-123
                    id
                    ind-span-76f5c8ed1c60aefb8736
                    label id
                    44cadee9-19ca-4756-ab85-0836b38db89f
                    positive predicate support span
                    Source null
                    qualifier mentions
                      regulatory links
                        schema version
                        0.1.0
                        source batch sha256
                        d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                        source defined aliases
                          source span
                          end
                          936
                          end exclusive
                          true
                          exact text
                          ( 1.2 ) Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for: selecting a therapeutic intervention or for monitoring the response to therapy; using the H/M ratio to identify a patient with a high risk for death.
                          label id
                          44cadee9-19ca-4756-ab85-0836b38db89f
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                          start
                          669
                          source url
                          https://api.fda.gov/drug/label.json?search=id%3A%2244cadee9-19ca-4756-ab85-0836b38db89f%22
                          spl effective date
                          2024-01-10
                          spl set id
                          c89d3ecc-4f4c-4566-8808-79152344194d
                          spl version
                          9
                          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
                          not_applicable
                          Passage 4 · positive indication candidate
                          application numbers
                          1. NDA022290
                          brand names
                          1. AdreView
                          classification reasons
                          1. explicit_positive_indication_predicate
                          2. diagnostic_use_words
                          clinical review status
                          pending
                          content role
                          positive_indication_candidate
                          context span
                          end
                          1344
                          end exclusive
                          true
                          exact text
                          e, AdreView utility has not been established for: selecting a therapeutic intervention or for monitoring the response to therapy; using the H/M ratio to identify a patient with a high risk for death. 1.1 Pheochromocytoma and Neuroblastoma AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. 1.2 Congestive Heart Failure AdreView is indicated for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity up
                          label id
                          44cadee9-19ca-4756-ab85-0836b38db89f
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                          start
                          737
                          current approval status
                          not_reconciled
                          duplicate text group
                          dup-5e2c9ccafd493cd58a67
                          extraction review status
                          automated_candidate_pending_source_review
                          generic names
                          1. IOBENGUANE I-123
                          id
                          ind-span-14b3f4daceb19c43f786
                          label id
                          44cadee9-19ca-4756-ab85-0836b38db89f
                          positive predicate support span
                          end
                          1019
                          end exclusive
                          true
                          exact text
                          is a radiopharmaceutical indicated
                          label id
                          44cadee9-19ca-4756-ab85-0836b38db89f
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                          start
                          985
                          qualifier mentions
                          1. context exact
                            maceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.
                            kind
                            biomarker
                            polarity
                            not_inferred
                            span
                            end
                            1102
                            end exclusive
                            true
                            exact text
                            metastatic pheochromocytoma or neuroblastom
                            label id
                            44cadee9-19ca-4756-ab85-0836b38db89f
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                            start
                            1059
                          2. context exact
                            maceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.
                            kind
                            stage_or_setting
                            polarity
                            not_inferred
                            span
                            end
                            1104
                            end exclusive
                            true
                            exact text
                            metastatic pheochromocytoma or neuroblastoma
                            label id
                            44cadee9-19ca-4756-ab85-0836b38db89f
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                            start
                            1059
                          regulatory links
                            schema version
                            0.1.0
                            source batch sha256
                            d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                            source defined aliases
                              source span
                              end
                              1144
                              end exclusive
                              true
                              exact text
                              1.1 Pheochromocytoma and Neuroblastoma AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.
                              label id
                              44cadee9-19ca-4756-ab85-0836b38db89f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                              start
                              937
                              source url
                              https://api.fda.gov/drug/label.json?search=id%3A%2244cadee9-19ca-4756-ab85-0836b38db89f%22
                              spl effective date
                              2024-01-10
                              spl set id
                              c89d3ecc-4f4c-4566-8808-79152344194d
                              spl version
                              9
                              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 5 · positive indication candidate
                              application numbers
                              1. NDA022290
                              brand names
                              1. AdreView
                              classification reasons
                              1. explicit_positive_indication_predicate
                              2. no_tumor_directed_keyword_in_positive_statement
                              clinical review status
                              pending
                              content role
                              positive_indication_candidate
                              context span
                              end
                              1688
                              end exclusive
                              true
                              exact text
                              chromocytoma and Neuroblastoma AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. 1.2 Congestive Heart Failure AdreView is indicated for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6. Limitations of Use: In patients with congestive h
                              label id
                              44cadee9-19ca-4756-ab85-0836b38db89f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                              start
                              945
                              current approval status
                              not_reconciled
                              duplicate text group
                              dup-c15c16610eb3f0bb9eeb
                              extraction review status
                              automated_candidate_pending_source_review
                              generic names
                              1. IOBENGUANE I-123
                              id
                              ind-span-f5a768b0f4f550c4d9af
                              label id
                              44cadee9-19ca-4756-ab85-0836b38db89f
                              positive predicate support span
                              end
                              1195
                              end exclusive
                              true
                              exact text
                              is indicated
                              label id
                              44cadee9-19ca-4756-ab85-0836b38db89f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                              start
                              1183
                              qualifier mentions
                                regulatory links
                                  schema version
                                  0.1.0
                                  source batch sha256
                                  d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                  source defined aliases
                                    source span
                                    end
                                    1488
                                    end exclusive
                                    true
                                    exact text
                                    1.2 Congestive Heart Failure AdreView is indicated for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%.
                                    label id
                                    44cadee9-19ca-4756-ab85-0836b38db89f
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                                    start
                                    1145
                                    source url
                                    https://api.fda.gov/drug/label.json?search=id%3A%2244cadee9-19ca-4756-ab85-0836b38db89f%22
                                    spl effective date
                                    2024-01-10
                                    spl set id
                                    c89d3ecc-4f4c-4566-8808-79152344194d
                                    spl version
                                    9
                                    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
                                    non_oncology_or_unclear_candidate
                                    Passage 6 · unclassified context
                                    application numbers
                                    1. NDA022290
                                    brand names
                                    1. AdreView
                                    classification reasons
                                    1. no_unambiguous_positive_indication_predicate
                                    clinical review status
                                    pending
                                    content role
                                    unclassified_context
                                    context span
                                    end
                                    1838
                                    end exclusive
                                    true
                                    exact text
                                    he heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6. Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for: selecting a therapeutic intervention or for monitoring the response to therapy; using the
                                    label id
                                    44cadee9-19ca-4756-ab85-0836b38db89f
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                                    start
                                    1289
                                    current approval status
                                    not_reconciled
                                    duplicate text group
                                    dup-bec80907eaf9260e292e
                                    extraction review status
                                    automated_candidate_pending_source_review
                                    generic names
                                    1. IOBENGUANE I-123
                                    id
                                    ind-span-e310572adbc877cea496
                                    label id
                                    44cadee9-19ca-4756-ab85-0836b38db89f
                                    positive predicate support span
                                    Source null
                                    qualifier mentions
                                      regulatory links
                                        schema version
                                        0.1.0
                                        source batch sha256
                                        d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                        source defined aliases
                                          source span
                                          end
                                          1638
                                          end exclusive
                                          true
                                          exact text
                                          Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6.
                                          label id
                                          44cadee9-19ca-4756-ab85-0836b38db89f
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                                          start
                                          1489
                                          source url
                                          https://api.fda.gov/drug/label.json?search=id%3A%2244cadee9-19ca-4756-ab85-0836b38db89f%22
                                          spl effective date
                                          2024-01-10
                                          spl set id
                                          c89d3ecc-4f4c-4566-8808-79152344194d
                                          spl version
                                          9
                                          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
                                          Passage 7 · limitation of use
                                          application numbers
                                          1. NDA022290
                                          brand names
                                          1. AdreView
                                          classification reasons
                                          1. negative_or_not_established_clause
                                          clinical review status
                                          pending
                                          content role
                                          limitation_of_use
                                          context span
                                          end
                                          1898
                                          end exclusive
                                          true
                                          exact text
                                          left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6. Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for: selecting a therapeutic intervention or for monitoring the response to therapy; using the H/M ratio to identify a patient with a high risk for death.
                                          label id
                                          44cadee9-19ca-4756-ab85-0836b38db89f
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                                          start
                                          1439
                                          current approval status
                                          not_reconciled
                                          duplicate text group
                                          dup-7db12a2cc0729873a72b
                                          extraction review status
                                          automated_candidate_pending_source_review
                                          generic names
                                          1. IOBENGUANE I-123
                                          id
                                          ind-span-cf108b7f7d14e4a59d7a
                                          label id
                                          44cadee9-19ca-4756-ab85-0836b38db89f
                                          positive predicate support span
                                          Source null
                                          qualifier mentions
                                            regulatory links
                                              schema version
                                              0.1.0
                                              source batch sha256
                                              d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                              source defined aliases
                                                source span
                                                end
                                                1898
                                                end exclusive
                                                true
                                                exact text
                                                Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for: selecting a therapeutic intervention or for monitoring the response to therapy; using the H/M ratio to identify a patient with a high risk for death.
                                                label id
                                                44cadee9-19ca-4756-ab85-0836b38db89f
                                                offset unit
                                                unicode_code_points
                                                source array index
                                                0
                                                source field
                                                indications_and_usage_exact
                                                source text sha256
                                                e887872910608601784058d3791bea4a52e82f50fbabce5d9a428192ebc779c6
                                                start
                                                1639
                                                source url
                                                https://api.fda.gov/drug/label.json?search=id%3A%2244cadee9-19ca-4756-ab85-0836b38db89f%22
                                                spl effective date
                                                2024-01-10
                                                spl set id
                                                c89d3ecc-4f4c-4566-8808-79152344194d
                                                spl version
                                                9
                                                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
                                                not_applicable

                                                Preserved source evidence · Not medical advice