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LABELS · 0d9200dd-878e-4e93-98af-e1149e84c21f

Orgovyx

Open original source → · Download preserved record

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

Label effective date
2025-10-10
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).
Full extracted label fields
application numbers
  1. NDA214621
boxed warning exact
    brand names
    1. Orgovyx
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=077a92f6-9f1b-479a-87c7-c92b5db6aa9c
    generic names
    1. RELUGOLIX
    id
    0d9200dd-878e-4e93-98af-e1149e84c21f
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Sumitomo Pharma America, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 72974-120-01
      2. 72974-120-97
      3. 72974-120-95
      product ndcs
      1. 72974-120
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2472783
        2. 2472789
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00000.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
        0
        total
        830
        sha256
        0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
        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=0&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%220d9200dd-878e-4e93-98af-e1149e84c21f%22
        spl effective date
        2025-10-10
        spl effective time
        20251010
        spl set id
        077a92f6-9f1b-479a-87c7-c92b5db6aa9c
        spl version
        12
        substance names
        1. RELUGOLIX
        uniis
        1. P76B05O5V6
        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
          NDA214621
          payload
          all indexed label documents
          1. Appl No
            214621
            Application Docs Date
            2020-12-18 00:00:00
            Application Docs ID
            65622
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            214621
            Application Docs Date
            2023-03-31 00:00:00
            Application Docs ID
            73916
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          3. Appl No
            214621
            Application Docs Date
            2024-10-21 00:00:00
            Application Docs ID
            79941
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          4. Appl No
            214621
            Application Docs Date
            2025-10-09 00:00:00
            Application Docs ID
            83697
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            214621
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2020-12-18 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            214621
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2023-03-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            214621
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2024-10-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            214621
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            12
            Submission Status
            AP
            Submission Status Date
            2025-10-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA214621
          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
          2025-10-08
          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
            214621
            Application Docs Date
            2025-10-09 00:00:00
            Application Docs ID
            83697
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          official application record
          Appl No
          214621
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          SUMITOMO PHARMA AM
          openfda application present
          true
          products
          1. Active Ingredient
            RELUGOLIX
            Appl No
            214621
            Drug Name
            ORGOVYX
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            120MG
            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. NDA214621
        brand names
        1. Orgovyx
        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
        265
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).
        label id
        0d9200dd-878e-4e93-98af-e1149e84c21f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        94b4c996e8a55f9f9273f26158ed493a5c715f790ae80b3a82e977adc7369ab5
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-88b086d137d2dc92787a
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. RELUGOLIX
        id
        ind-span-a587463ed052d3b7eb98
        label id
        0d9200dd-878e-4e93-98af-e1149e84c21f
        positive predicate support span
        end
        44
        end exclusive
        true
        exact text
        is indicated
        label id
        0d9200dd-878e-4e93-98af-e1149e84c21f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        94b4c996e8a55f9f9273f26158ed493a5c715f790ae80b3a82e977adc7369ab5
        start
        32
        qualifier mentions
        1. context exact
          CATIONS AND USAGE ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer.
          kind
          age
          polarity
          not_inferred
          span
          end
          80
          end exclusive
          true
          exact text
          adult patients
          label id
          0d9200dd-878e-4e93-98af-e1149e84c21f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          94b4c996e8a55f9f9273f26158ed493a5c715f790ae80b3a82e977adc7369ab5
          start
          66
        2. context exact
          GOVYX is indicated for the treatment of adult patients with advanced prostate cancer.
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          110
          end exclusive
          true
          exact text
          advanced prostate cancer
          label id
          0d9200dd-878e-4e93-98af-e1149e84c21f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          94b4c996e8a55f9f9273f26158ed493a5c715f790ae80b3a82e977adc7369ab5
          start
          86
        regulatory links
          schema version
          0.1.0
          source batch sha256
          0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
          source defined aliases
            source span
            end
            111
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer.
            label id
            0d9200dd-878e-4e93-98af-e1149e84c21f
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            94b4c996e8a55f9f9273f26158ed493a5c715f790ae80b3a82e977adc7369ab5
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%220d9200dd-878e-4e93-98af-e1149e84c21f%22
            spl effective date
            2025-10-10
            spl set id
            077a92f6-9f1b-479a-87c7-c92b5db6aa9c
            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. NDA214621
            brand names
            1. Orgovyx
            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
            265
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).
            label id
            0d9200dd-878e-4e93-98af-e1149e84c21f
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            94b4c996e8a55f9f9273f26158ed493a5c715f790ae80b3a82e977adc7369ab5
            start
            0
            current approval status
            not_reconciled
            duplicate text group
            dup-fd380ffbf9c1fdd9575e
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. RELUGOLIX
            id
            ind-span-482c39902e5907a9ff3f
            label id
            0d9200dd-878e-4e93-98af-e1149e84c21f
            positive predicate support span
            end
            192
            end exclusive
            true
            exact text
            is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated
            label id
            0d9200dd-878e-4e93-98af-e1149e84c21f
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
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            start
            120
            qualifier mentions
            1. context exact
              e (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).
              kind
              age
              polarity
              not_inferred
              span
              end
              228
              end exclusive
              true
              exact text
              adult patients
              label id
              0d9200dd-878e-4e93-98af-e1149e84c21f
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              94b4c996e8a55f9f9273f26158ed493a5c715f790ae80b3a82e977adc7369ab5
              start
              214
            2. context exact
              tagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).
              kind
              stage_or_setting
              polarity
              not_inferred
              span
              end
              264
              end exclusive
              true
              exact text
              advanced prostate cancer ( 1 )
              label id
              0d9200dd-878e-4e93-98af-e1149e84c21f
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              94b4c996e8a55f9f9273f26158ed493a5c715f790ae80b3a82e977adc7369ab5
              start
              234
            regulatory links
              schema version
              0.1.0
              source batch sha256
              0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
              source defined aliases
                source span
                end
                265
                end exclusive
                true
                exact text
                ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).
                label id
                0d9200dd-878e-4e93-98af-e1149e84c21f
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                94b4c996e8a55f9f9273f26158ed493a5c715f790ae80b3a82e977adc7369ab5
                start
                112
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%220d9200dd-878e-4e93-98af-e1149e84c21f%22
                spl effective date
                2025-10-10
                spl set id
                077a92f6-9f1b-479a-87c7-c92b5db6aa9c
                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