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LABELS · 7997d826-eb49-4688-9833-e668985c1e74

Demser

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
2021-07-01
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE DEMSER is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma DEMSER is not recommended for the control of essential hypertension.
Full extracted label fields
application numbers
  1. NDA017871
boxed warning exact
    brand names
    1. Demser
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92
    generic names
    1. METYROSINE
    id
    7997d826-eb49-4688-9833-e668985c1e74
    indications and usage exact
    1. INDICATIONS AND USAGE DEMSER is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma DEMSER is not recommended for the control of essential hypertension.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Bausch Health US, LLC
      matched search terms
      1. malignant
      2. pheochromocytoma
      package ndcs
      1. 25010-305-15
      product ndcs
      1. 25010-305
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 197980
        2. 201388
        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
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        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%227997d826-eb49-4688-9833-e668985c1e74%22
        spl effective date
        2021-07-01
        spl effective time
        20210701
        spl set id
        32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92
        spl version
        10
        substance names
        1. METYROSINE
        uniis
        1. DOQ0J0TPF7
        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
          NDA017871
          payload
          all indexed label documents
            all submission records
            1. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              7
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              1979-10-03 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            2. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              3
              Submission Status
              AP
              Submission Status Date
              1980-11-14 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              4
              Submission Status
              AP
              Submission Status Date
              1984-01-25 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              017871
              Review Priority
              Submission Class Code ID
              3
              Submission No
              5
              Submission Status
              AP
              Submission Status Date
              1985-09-06 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              017871
              Review Priority
              Submission Class Code ID
              3
              Submission No
              6
              Submission Status
              AP
              Submission Status Date
              1985-11-01 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            6. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              7
              Submission Status
              AP
              Submission Status Date
              1988-07-07 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            7. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              8
              Submission Status
              AP
              Submission Status Date
              1987-12-23 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            8. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              9
              Submission Status
              AP
              Submission Status Date
              1994-03-16 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            9. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              10
              Submission Status
              AP
              Submission Status Date
              2001-12-12 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            10. Appl No
              017871
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              11
              Submission Status
              AP
              Submission Status Date
              2003-05-30 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            11. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              18
              Submission Status
              AP
              Submission Status Date
              2013-11-08 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            12. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              19
              Submission Status
              AP
              Submission Status Date
              2014-07-15 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA017871
            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
            2014-07-15
            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
              official application record
              Appl No
              017871
              Appl Public Notes
              Appl Type
              NDA
              Sponsor Name
              BAUSCH
              openfda application present
              true
              products
              1. Active Ingredient
                METYROSINE
                Appl No
                017871
                Drug Name
                DEMSER
                Form
                CAPSULE;ORAL
                Product No
                001
                Reference Drug
                1
                Reference Standard
                1
                Strength
                250MG
                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. NDA017871
            brand names
            1. Demser
            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
            300
            end exclusive
            true
            exact text
            INDICATIONS AND USAGE DEMSER is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma DEMSER is not recommended f
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            duplicate text group
            dup-7facb9555ff04dd199d4
            extraction review status
            automated_candidate_pending_source_review
            generic names
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            positive predicate support span
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            exact text
            is indicated
            label id
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            qualifier mentions
              regulatory links
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                  INDICATIONS AND USAGE DEMSER is indicated in the treatment of patients with pheochromocytoma for: 1.
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                  spl effective date
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                  structured indication
                  age
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                  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 · unclassified context
                  application numbers
                  1. NDA017871
                  brand names
                  1. Demser
                  classification reasons
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                  clinical review status
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                  content role
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                  341
                  end exclusive
                  true
                  exact text
                  INDICATIONS AND USAGE DEMSER is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma DEMSER is not recommended for the control of essential hypertension.
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                  positive predicate support span
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                        exact text
                        Preoperative preparation of patients for surgery 2.
                        label id
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                        offset unit
                        unicode_code_points
                        source array index
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                        source field
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                        source text sha256
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                        source url
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                        spl effective date
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                        spl set id
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                        spl version
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                        structured fields status
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                        structured indication
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                        Source null
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                        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 3 · risk or warning
                        application numbers
                        1. NDA017871
                        brand names
                        1. Demser
                        classification reasons
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                        clinical review status
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                        content role
                        risk_or_warning
                        context span
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                        341
                        end exclusive
                        true
                        exact text
                        INDICATIONS AND USAGE DEMSER is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma DEMSER is not recommended for the control of essential hypertension.
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                              Management of patients when surgery is contraindicated 3.
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                              source url
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                              spl effective date
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                              spl set id
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                              spl version
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                              approval pathway
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                              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
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                              Passage 4 · limitation of use
                              application numbers
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                              brand names
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                              clinical review status
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                              end exclusive
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                              exact text
                              AND USAGE DEMSER is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma DEMSER is not recommended for the control of essential hypertension.
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                                    exact text
                                    Chronic treatment of patients with malignant pheochromocytoma DEMSER is not recommended for the control of essential hypertension.
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                                    source url
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                                    spl effective date
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                                    biomarker and test
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                                    disease stage
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                                    line
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                                    Source null
                                    regimen
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                                    tumor histology
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                                    use intent
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                                    Preserved source evidence · Not medical advice