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LABELS · cca29ff5-d000-43da-b64a-c65816a8a9c4

Rylaze

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
2025-07-01
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. RYLAZE is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. ( 1 )
Full extracted label fields
application numbers
  1. BLA761179
boxed warning exact
    brand names
    1. Rylaze
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=857e53aa-1098-4dad-b654-0276cdd43e03
    generic names
    1. ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN
    id
    cca29ff5-d000-43da-b64a-c65816a8a9c4
    indications and usage exact
    1. 1 INDICATIONS AND USAGE RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. RYLAZE is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Jazz Pharmaceuticals, Inc.
      matched search terms
      1. lymphoma
      2. leukemia
      package ndcs
      1. 68727-900-01
      2. 68727-900-03
      product ndcs
      1. 68727-900
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAMUSCULAR
        rxcuis
        1. 2561251
        2. 2561256
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00600.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
        600
        total
        830
        sha256
        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
        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=600&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22cca29ff5-d000-43da-b64a-c65816a8a9c4%22
        spl effective date
        2025-07-01
        spl effective time
        20250701
        spl set id
        857e53aa-1098-4dad-b654-0276cdd43e03
        spl version
        7
        substance names
        1. ASPARAGINASE
        uniis
        1. G4FQ3CKY5R
        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
          BLA761179
          payload
          all indexed label documents
          1. Appl No
            761179
            Application Docs Date
            2021-07-01 00:00:00
            Application Docs ID
            67996
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            761179
            Application Docs Date
            2022-11-24 00:00:00
            Application Docs ID
            72694
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            761179
            Application Docs Date
            2024-04-16 00:00:00
            Application Docs ID
            78150
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            761179
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2021-06-30 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            761179
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2022-11-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            761179
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2021-07-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            761179
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2024-04-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          BLA761179
          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
          2024-04-15
          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
          1. Appl No
            761179
            Application Docs Date
            2024-04-16 00:00:00
            Application Docs ID
            78150
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          official application record
          Appl No
          761179
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          JAZZ PHARMS
          openfda application present
          true
          products
          1. Active Ingredient
            ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN
            Appl No
            761179
            Drug Name
            RYLAZE
            Form
            INJECTABLE;INTRAMUSCULAR
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            10MG/0.5ML
            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. BLA761179
        brand names
        1. Rylaze
        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
        508
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. RYLAZE is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in
        label id
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        offset unit
        unicode_code_points
        source array index
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        source field
        indications_and_usage_exact
        source text sha256
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        start
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        current approval status
        not_reconciled
        duplicate text group
        dup-6fe97338445c3b93e373
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN
        id
        ind-span-e531fcc71cf501d689be
        label id
        cca29ff5-d000-43da-b64a-c65816a8a9c4
        positive predicate support span
        end
        43
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        true
        exact text
        is indicated
        label id
        cca29ff5-d000-43da-b64a-c65816a8a9c4
        offset unit
        unicode_code_points
        source array index
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        source field
        indications_and_usage_exact
        source text sha256
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        start
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        qualifier mentions
        1. context exact
          oblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed
          kind
          age
          polarity
          not_inferred
          span
          end
          198
          end exclusive
          true
          exact text
          adult
          label id
          cca29ff5-d000-43da-b64a-c65816a8a9c4
          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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          start
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        2. context exact
          eukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E.
          kind
          age
          polarity
          not_inferred
          span
          end
          221
          end exclusive
          true
          exact text
          pediatric patients
          label id
          cca29ff5-d000-43da-b64a-c65816a8a9c4
          offset unit
          unicode_code_points
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          0
          source field
          indications_and_usage_exact
          source text sha256
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        regulatory links
          schema version
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          source defined aliases
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            true
            exact text
            1 INDICATIONS AND USAGE RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase.
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            offset unit
            unicode_code_points
            source array index
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            source field
            indications_and_usage_exact
            source text sha256
            eb4d7acf0886e2a78a6a3f3b9923f081b48dd8968424d2f1b39ba4e4ac36bdcb
            start
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            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22cca29ff5-d000-43da-b64a-c65816a8a9c4%22
            spl effective date
            2025-07-01
            spl set id
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            spl version
            7
            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. BLA761179
            brand names
            1. Rylaze
            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
            629
            end exclusive
            true
            exact text
            treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. RYLAZE is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. ( 1 )
            label id
            cca29ff5-d000-43da-b64a-c65816a8a9c4
            offset unit
            unicode_code_points
            source array index
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            source field
            indications_and_usage_exact
            source text sha256
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            start
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            current approval status
            not_reconciled
            duplicate text group
            dup-e070fa4bdee3707cd697
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN
            id
            ind-span-12a1cfdac3dbc4b2f8ab
            label id
            cca29ff5-d000-43da-b64a-c65816a8a9c4
            positive predicate support span
            end
            358
            end exclusive
            true
            exact text
            is an asparagine specific enzyme indicated
            label id
            cca29ff5-d000-43da-b64a-c65816a8a9c4
            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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            qualifier mentions
            1. context exact
              oblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed
              kind
              age
              polarity
              not_inferred
              span
              end
              513
              end exclusive
              true
              exact text
              adult
              label id
              cca29ff5-d000-43da-b64a-c65816a8a9c4
              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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              start
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            2. context exact
              eukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E.
              kind
              age
              polarity
              not_inferred
              span
              end
              536
              end exclusive
              true
              exact text
              pediatric patients
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              source field
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            regulatory links
              schema version
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              source defined aliases
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                true
                exact text
                RYLAZE is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase.
                label id
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                offset unit
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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
                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 3 · unclassified context
                application numbers
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                brand names
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                classification reasons
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                clinical review status
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                content role
                unclassified_context
                context span
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                629
                end exclusive
                true
                exact text
                treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. ( 1 )
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                current approval status
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                duplicate text group
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                extraction review status
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                generic names
                1. ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN
                id
                ind-span-dc7021e44c394abf9b06
                label id
                cca29ff5-d000-43da-b64a-c65816a8a9c4
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
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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