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LABELS · 763f89b2-723c-410d-b3b6-cc001c16c3ca

CRYSVITA

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
2026-04-22
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 CRYSVITA is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for: The treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. ( 1.1 ) The treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older. ( 1.2 ) 1.1 X-linked Hypophosphatemia CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. 1.2 Tumor-induced Osteomalacia CRYSVITA is indicated for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older.
Full extracted label fields
application numbers
  1. BLA761068
boxed warning exact
    brand names
    1. CRYSVITA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=102f96a0-6e3a-4fc1-b204-34d604683af6
    generic names
    1. BUROSUMAB
    id
    763f89b2-723c-410d-b3b6-cc001c16c3ca
    indications and usage exact
    1. 1 INDICATIONS AND USAGE CRYSVITA is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for: The treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. ( 1.1 ) The treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older. ( 1.2 ) 1.1 X-linked Hypophosphatemia CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. 1.2 Tumor-induced Osteomalacia CRYSVITA is indicated for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Kyowa Kirin, Inc.
      matched search terms
      1. tumor
      2. tumors
      package ndcs
      1. 42747-102-01
      2. 42747-203-01
      3. 42747-304-01
      product ndcs
      1. 42747-102
      2. 42747-203
      3. 42747-304
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.3 ) 4/2026 Warnings and Precautions, Hypercalcemia ( 5.3 ) 8/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. SUBCUTANEOUS
      rxcuis
      1. 2043859
      2. 2043864
      3. 2043868
      4. 2043870
      5. 2043876
      6. 2043878
      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%22763f89b2-723c-410d-b3b6-cc001c16c3ca%22
      spl effective date
      2026-04-22
      spl effective time
      20260422
      spl set id
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      spl version
      7
      substance names
      1. BUROSUMAB
      uniis
      1. G9WJT6RD29
      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
      4. fda_label_posted_after_spl_effective_date_requires_version_review
      Drugs@FDA application source records
      1. application number
        BLA761068
        payload
        all indexed label documents
        1. Appl No
          761068
          Application Docs Date
          2018-04-17 00:00:00
          Application Docs ID
          53709
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761068
          Application Docs Date
          2019-10-01 00:00:00
          Application Docs ID
          60184
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        3. Appl No
          761068
          Application Docs Date
          2019-10-07 00:00:00
          Application Docs ID
          60253
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        4. Appl No
          761068
          Application Docs Date
          2020-06-22 00:00:00
          Application Docs ID
          63651
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        5. Appl No
          761068
          Application Docs Date
          2025-09-02 00:00:00
          Application Docs ID
          83258
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        6. Appl No
          761068
          Application Docs Date
          2026-04-24 00:00:00
          Application Docs ID
          85751
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          761068
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2018-04-17 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          761068
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2019-09-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          761068
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2019-09-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          761068
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2020-06-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          761068
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2025-08-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          761068
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2026-04-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761068
        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
        2026-04-23
        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
          761068
          Application Docs Date
          2026-04-24 00:00:00
          Application Docs ID
          85751
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        official application record
        Appl No
        761068
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        KYOWA KIRIN
        openfda application present
        true
        products
        1. Active Ingredient
          BUROSUMAB-TWZA
          Appl No
          761068
          Drug Name
          CRYSVITA
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          2
          Reference Standard
          0
          Strength
          10MG/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. BLA761068
      brand names
      1. CRYSVITA
      classification reasons
      1. explicit_positive_indication_predicate
      2. no_tumor_directed_keyword_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      414
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE CRYSVITA is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for: The treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. ( 1.1 ) The treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult an
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      generic names
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      exact text
      is a fibroblast growth factor 23 (FGF23) blocking antibody indicated
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      qualifier mentions
      1. context exact
        ed for: The treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.
        kind
        age
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      2. context exact
        e treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.
        kind
        age
        polarity
        not_inferred
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        end
        187
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      regulatory links
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          true
          exact text
          1 INDICATIONS AND USAGE CRYSVITA is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for: The treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.
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          source url
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          spl effective date
          2026-04-22
          spl set id
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          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
          non_oncology_or_unclear_candidate
          Passage 2 · positive indication candidate
          application numbers
          1. BLA761068
          brand names
          1. CRYSVITA
          classification reasons
          1. inherited_predicate_from_same_label_section_requires_review
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          clinical review status
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          context span
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          660
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          true
          exact text
          ND USAGE CRYSVITA is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for: The treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. ( 1.1 ) The treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older. ( 1.2 ) 1.1 X-linked Hypophosphatemia CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. 1.2 Tumor-induced Osteomala
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          generic names
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          label id
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          exact text
          is a fibroblast growth factor 23 (FGF23) blocking antibody indicated
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          qualifier mentions
          1. context exact
            l tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older.
            kind
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            polarity
            not_inferred
            span
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          2. context exact
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              ( 1.1 ) The treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older.
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              limitations
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              prior therapy
              Source null
              regimen
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              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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              true
              exact text
              sphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older. ( 1.2 ) 1.1 X-linked Hypophosphatemia CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. 1.2 Tumor-induced Osteomalacia CRYS
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                    ( 1.2 )
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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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