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

LABELS · 74d44dec-f079-43b7-94ac-989a948f53ec

Lutathera

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
2026-01-15
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. LUTATHERA is a radiolabeled somatostatin analog indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
Full extracted label fields
application numbers
  1. NDA208700
boxed warning exact
    brand names
    1. Lutathera
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55
    generic names
    1. LUTETIUM LU 177 DOTATATE
    id
    74d44dec-f079-43b7-94ac-989a948f53ec
    indications and usage exact
    1. 1 INDICATIONS AND USAGE LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. LUTATHERA is a radiolabeled somatostatin analog indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Advanced Accelerator Applications USA, Inc
      matched search terms
      1. tumors
      package ndcs
      1. 69488-003-01
      product ndcs
      1. 69488-003
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1 ) 4/2024 Dosage and Administration ( 2.2 , 2.5 , 2.6 ) 4/2024 Warnings and Precautions ( 5.1 ) 4/2024
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 1999682
      2. 1999687
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00400.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      400
      total
      830
      sha256
      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
      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=400&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%2274d44dec-f079-43b7-94ac-989a948f53ec%22
      spl effective date
      2026-01-15
      spl effective time
      20260115
      spl set id
      72d1a024-00b7-418a-b36e-b2cb48f2ab55
      spl version
      12
      substance names
      1. LUTETIUM OXODOTREOTIDE LU-177
      uniis
      1. AE221IM3BB
      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
        NDA208700
        payload
        all indexed label documents
        1. Appl No
          208700
          Application Docs Date
          2018-01-26 00:00:00
          Application Docs ID
          51796
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          208700
          Application Docs Date
          2020-05-29 00:00:00
          Application Docs ID
          63350
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          208700
          Application Docs Date
          2022-06-15 00:00:00
          Application Docs ID
          71332
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          19
          Submission Type
          SUPPL
        4. Appl No
          208700
          Application Docs Date
          2022-06-16 00:00:00
          Application Docs ID
          71334
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          23
          Submission Type
          SUPPL
        5. Appl No
          208700
          Application Docs Date
          2023-03-08 00:00:00
          Application Docs ID
          73707
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          26
          Submission Type
          SUPPL
        6. Appl No
          208700
          Application Docs Date
          2024-04-23 00:00:00
          Application Docs ID
          78223
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          31
          Submission Type
          SUPPL
        7. Appl No
          208700
          Application Docs Date
          2024-12-05 00:00:00
          Application Docs ID
          80509
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          32
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          208700
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2018-01-26 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          208700
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2020-05-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          208700
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2020-05-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          208700
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          19
          Submission Status
          AP
          Submission Status Date
          2022-06-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          208700
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          20
          Submission Status
          AP
          Submission Status Date
          2022-06-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          208700
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          23
          Submission Status
          AP
          Submission Status Date
          2022-06-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          208700
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          26
          Submission Status
          AP
          Submission Status Date
          2023-03-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          208700
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          31
          Submission Status
          AP
          Submission Status Date
          2024-04-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          208700
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          32
          Submission Status
          AP
          Submission Status Date
          2024-11-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA208700
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2024-11-26
        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
          208700
          Application Docs Date
          2024-12-05 00:00:00
          Application Docs ID
          80509
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          32
          Submission Type
          SUPPL
        official application record
        Appl No
        208700
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        AAA USA INC
        openfda application present
        true
        products
        1. Active Ingredient
          LUTETIUM LU 177 DOTATATE
          Appl No
          208700
          Drug Name
          LUTATHERA
          Form
          SOLUTION;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          10mCi/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. NDA208700
      brand names
      1. Lutathera
      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
      470
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. LUTATHERA is a radiolabeled somatostatin analog indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrin
      label id
      74d44dec-f079-43b7-94ac-989a948f53ec
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      9aefada746cc2c93fec8778f17597de14e67ffeac1e40dd76b9d322539237d20
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-10d42c9203e8f94a908d
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. LUTETIUM LU 177 DOTATATE
      id
      ind-span-1659eeaffe23133de369
      label id
      74d44dec-f079-43b7-94ac-989a948f53ec
      positive predicate support span
      end
      46
      end exclusive
      true
      exact text
      is indicated
      label id
      74d44dec-f079-43b7-94ac-989a948f53ec
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      9aefada746cc2c93fec8778f17597de14e67ffeac1e40dd76b9d322539237d20
      start
      34
      qualifier mentions
      1. context exact
        TIONS AND USAGE LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin
        kind
        age
        polarity
        not_inferred
        span
        end
        73
        end exclusive
        true
        exact text
        adult
        label id
        74d44dec-f079-43b7-94ac-989a948f53ec
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        9aefada746cc2c93fec8778f17597de14e67ffeac1e40dd76b9d322539237d20
        start
        68
      2. context exact
        USAGE LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gast
        kind
        age
        polarity
        not_inferred
        span
        end
        96
        end exclusive
        true
        exact text
        pediatric patients
        label id
        74d44dec-f079-43b7-94ac-989a948f53ec
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        9aefada746cc2c93fec8778f17597de14e67ffeac1e40dd76b9d322539237d20
        start
        78
      3. context exact
        indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic
        kind
        age
        polarity
        not_inferred
        span
        end
        115
        end exclusive
        true
        exact text
        12 years and older
        label id
        74d44dec-f079-43b7-94ac-989a948f53ec
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        9aefada746cc2c93fec8778f17597de14e67ffeac1e40dd76b9d322539237d20
        start
        97
      regulatory links
        schema version
        0.1.0
        source batch sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        source defined aliases
          source span
          end
          270
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
          label id
          74d44dec-f079-43b7-94ac-989a948f53ec
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          9aefada746cc2c93fec8778f17597de14e67ffeac1e40dd76b9d322539237d20
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%2274d44dec-f079-43b7-94ac-989a948f53ec%22
          spl effective date
          2026-01-15
          spl set id
          72d1a024-00b7-418a-b36e-b2cb48f2ab55
          spl version
          12
          structured fields status
          not_extracted_no_values_inferred_from_mentions
          structured indication
          age
          Source null
          approval pathway
          Source null
          biomarker and test
          Source null
          disease stage
          Source null
          limitations
          Source null
          line
          Source null
          prior therapy
          Source null
          regimen
          Source null
          tumor histology
          Source null
          use intent
          tumor_directed_candidate
          Passage 2 · positive indication candidate
          application numbers
          1. NDA208700
          brand names
          1. Lutathera
          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
          552
          end exclusive
          true
          exact text
          lt and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. LUTATHERA is a radiolabeled somatostatin analog indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
          label id
          74d44dec-f079-43b7-94ac-989a948f53ec
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          9aefada746cc2c93fec8778f17597de14e67ffeac1e40dd76b9d322539237d20
          start
          71
          current approval status
          not_reconciled
          duplicate text group
          dup-89f9bdbf331a6b00d418
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. LUTETIUM LU 177 DOTATATE
          id
          ind-span-3b0d42ad83b90fc4be8f
          label id
          74d44dec-f079-43b7-94ac-989a948f53ec
          positive predicate support span
          end
          328
          end exclusive
          true
          exact text
          is a radiolabeled somatostatin analog indicated
          label id
          74d44dec-f079-43b7-94ac-989a948f53ec
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          9aefada746cc2c93fec8778f17597de14e67ffeac1e40dd76b9d322539237d20
          start
          281
          qualifier mentions
          1. context exact
            olabeled somatostatin analog indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin
            kind
            age
            polarity
            not_inferred
            span
            end
            355
            end exclusive
            true
            exact text
            adult
            label id
            74d44dec-f079-43b7-94ac-989a948f53ec
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9aefada746cc2c93fec8778f17597de14e67ffeac1e40dd76b9d322539237d20
            start
            350
          2. context exact
            omatostatin analog indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gast
            kind
            age
            polarity
            not_inferred
            span
            end
            378
            end exclusive
            true
            exact text
            pediatric patients
            label id
            74d44dec-f079-43b7-94ac-989a948f53ec
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9aefada746cc2c93fec8778f17597de14e67ffeac1e40dd76b9d322539237d20
            start
            360
          3. context exact
            indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic
            kind
            age
            polarity
            not_inferred
            span
            end
            397
            end exclusive
            true
            exact text
            12 years and older
            label id
            74d44dec-f079-43b7-94ac-989a948f53ec
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9aefada746cc2c93fec8778f17597de14e67ffeac1e40dd76b9d322539237d20
            start
            379
          regulatory links
            schema version
            0.1.0
            source batch sha256
            a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
            source defined aliases
              source span
              end
              552
              end exclusive
              true
              exact text
              LUTATHERA is a radiolabeled somatostatin analog indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
              label id
              74d44dec-f079-43b7-94ac-989a948f53ec
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              9aefada746cc2c93fec8778f17597de14e67ffeac1e40dd76b9d322539237d20
              start
              271
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%2274d44dec-f079-43b7-94ac-989a948f53ec%22
              spl effective date
              2026-01-15
              spl set id
              72d1a024-00b7-418a-b36e-b2cb48f2ab55
              spl version
              12
              structured fields status
              not_extracted_no_values_inferred_from_mentions
              structured indication
              age
              Source null
              approval pathway
              Source null
              biomarker and test
              Source null
              disease stage
              Source null
              limitations
              Source null
              line
              Source null
              prior therapy
              Source null
              regimen
              Source null
              tumor histology
              Source null
              use intent
              tumor_directed_candidate

              Preserved source evidence · Not medical advice