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LABELS · 27e98e6d-9faf-3a94-e063-6394a90a1dcb

MOVANTIK

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
2024-11-27
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE MOVANTIK ® is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. MOVANTIK is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1)
Full extracted label fields
application numbers
  1. NDA204760
boxed warning exact
    brand names
    1. MOVANTIK
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=300a6474-ebcd-4404-8040-48fdcfcc1635
    generic names
    1. NALOXEGOL OXALATE
    id
    27e98e6d-9faf-3a94-e063-6394a90a1dcb
    indications and usage exact
    1. 1 INDICATIONS AND USAGE MOVANTIK ® is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. MOVANTIK is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1)
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. RedHill Biopharma Ltd
      matched search terms
      1. cancer
      package ndcs
      1. 57841-1300-1
      2. 57841-1300-2
      3. 57841-1300-3
      4. 57841-1300-4
      5. 57841-1301-1
      6. 57841-1301-2
      7. 57841-1301-3
      8. 57841-1301-4
      product ndcs
      1. 57841-1301
      2. 57841-1300
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions (5.3) 04/2020
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 1551782
      2. 1551917
      3. 1551923
      4. 1601373
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00100.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      100
      total
      830
      sha256
      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=100&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%2227e98e6d-9faf-3a94-e063-6394a90a1dcb%22
      spl effective date
      2024-11-27
      spl effective time
      20241127
      spl set id
      300a6474-ebcd-4404-8040-48fdcfcc1635
      spl version
      5
      substance names
      1. NALOXEGOL OXALATE
      uniis
      1. 65I14TNM33
      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
        NDA204760
        payload
        all indexed label documents
        1. Appl No
          204760
          Application Docs Date
          2014-09-19 00:00:00
          Application Docs ID
          19592
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          204760
          Application Docs Date
          2016-07-25 00:00:00
          Application Docs ID
          19593
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          204760
          Application Docs Date
          2016-08-23 00:00:00
          Application Docs ID
          45112
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        4. Appl No
          204760
          Application Docs Date
          2016-08-23 00:00:00
          Application Docs ID
          45113
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        5. Appl No
          204760
          Application Docs Date
          2017-08-03 00:00:00
          Application Docs ID
          49223
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        6. Appl No
          204760
          Application Docs Date
          2018-03-02 00:00:00
          Application Docs ID
          52798
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        7. Appl No
          204760
          Application Docs Date
          2019-05-30 00:00:00
          Application Docs ID
          58889
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        8. Appl No
          204760
          Application Docs Date
          2020-04-14 00:00:00
          Application Docs ID
          62554
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          204760
          Review Priority
          STANDARD
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2014-09-16 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          204760
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2016-07-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          204760
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2016-08-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          204760
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2016-08-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          204760
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2017-08-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          204760
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2018-02-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          204760
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2019-05-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          204760
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2020-04-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA204760
        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
        2020-04-13
        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
          204760
          Application Docs Date
          2020-04-14 00:00:00
          Application Docs ID
          62554
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        official application record
        Appl No
        204760
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        AVERITAS
        openfda application present
        true
        products
        1. Active Ingredient
          NALOXEGOL OXALATE
          Appl No
          204760
          Drug Name
          MOVANTIK
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 12.5MG BASE
          marketing status
          1. Prescription
        2. Active Ingredient
          NALOXEGOL OXALATE
          Appl No
          204760
          Drug Name
          MOVANTIK
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 25MG BASE
          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. NDA204760
      brand names
      1. MOVANTIK
      classification reasons
      1. explicit_positive_indication_predicate
      2. supportive_or_complication_use_words
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      497
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE MOVANTIK ® is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. MOVANTIK is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior
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      not_reconciled
      duplicate text group
      dup-2b8c8feba12dcd021354
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. NALOXEGOL OXALATE
      id
      ind-span-73af8df4681534a1622d
      label id
      27e98e6d-9faf-3a94-e063-6394a90a1dcb
      positive predicate support span
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      end exclusive
      true
      exact text
      is indicated
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      source text sha256
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      start
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      qualifier mentions
      1. context exact
        d for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chron
        kind
        age
        polarity
        not_inferred
        span
        end
        120
        end exclusive
        true
        exact text
        adult patients
        label id
        27e98e6d-9faf-3a94-e063-6394a90a1dcb
        offset unit
        unicode_code_points
        source array index
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        source field
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        source text sha256
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        start
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      regulatory links
        schema version
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        source batch sha256
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        source defined aliases
          source span
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          true
          exact text
          1 INDICATIONS AND USAGE MOVANTIK ® is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
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          source text sha256
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          start
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%2227e98e6d-9faf-3a94-e063-6394a90a1dcb%22
          spl effective date
          2024-11-27
          spl set id
          300a6474-ebcd-4404-8040-48fdcfcc1635
          spl version
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          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
          supportive_care_candidate
          Passage 2 · positive indication candidate
          application numbers
          1. NDA204760
          brand names
          1. MOVANTIK
          classification reasons
          1. explicit_positive_indication_predicate
          2. supportive_or_complication_use_words
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          594
          end exclusive
          true
          exact text
          OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. MOVANTIK is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1)
          label id
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          offset unit
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          source field
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          current approval status
          not_reconciled
          duplicate text group
          dup-81a585112c046ddff560
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. NALOXEGOL OXALATE
          id
          ind-span-4361e155263f57f8e617
          label id
          27e98e6d-9faf-3a94-e063-6394a90a1dcb
          positive predicate support span
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          end exclusive
          true
          exact text
          is an opioid antagonist indicated
          label id
          27e98e6d-9faf-3a94-e063-6394a90a1dcb
          offset unit
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          source text sha256
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          start
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          qualifier mentions
          1. context exact
            d for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chron
            kind
            age
            polarity
            not_inferred
            span
            end
            413
            end exclusive
            true
            exact text
            adult patients
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            27e98e6d-9faf-3a94-e063-6394a90a1dcb
            offset unit
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            source array index
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            source field
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            source text sha256
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          regulatory links
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            source defined aliases
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              end exclusive
              true
              exact text
              MOVANTIK is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
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              source url
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              spl effective date
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              spl set id
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              structured fields status
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              structured indication
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              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
              supportive_care_candidate
              Passage 3 · unclassified context
              application numbers
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              brand names
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              clinical review status
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              content role
              unclassified_context
              context span
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              end exclusive
              true
              exact text
              OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1)
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              generic names
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              id
              ind-span-61fb6cd33af5b44e47ea
              label id
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              positive predicate support span
              Source null
              qualifier mentions
                regulatory links
                  schema version
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                    (1)
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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
                    approval pathway
                    Source null
                    biomarker and test
                    Source null
                    disease stage
                    Source null
                    limitations
                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
                    unclear

                    Preserved source evidence · Not medical advice