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LABELS · d060dfe4-0d02-2d02-34f3-c31bfff5ab7a

Fulphila

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
2026-01-30
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 Fulphila is a leukocyte growth factor indicated to • Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1) ] . Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Full extracted label fields
application numbers
  1. BLA761075
boxed warning exact
    brand names
    1. Fulphila
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9bfc4d3e-6120-7fec-f1d6-0b3743752034
    generic names
    1. PEGFILGRASTIM-JMDB
    id
    d060dfe4-0d02-2d02-34f3-c31bfff5ab7a
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Fulphila is a leukocyte growth factor indicated to • Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1) ] . Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Biocon Biologics Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 83257-005-41
      product ndcs
      1. 83257-005
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Thrombocytopenia ( 5.7 ) 03/2021 Warnings and Precautions, Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) ( 5.10 ) 03/2021
      record type
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      1. SUBCUTANEOUS
      rxcuis
      1. 2048020
      2. 2048025
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      file
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      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.
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      1. PEGFILGRASTIM
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      1. application number
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        payload
        all indexed label documents
        1. Appl No
          761075
          Application Docs Date
          2018-06-04 00:00:00
          Application Docs ID
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          Application Docs Type ID
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        4. Appl No
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        5. Appl No
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          0
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          Submission No
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          STANDARD
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          Submission No
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        2. Appl No
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          STANDARD
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          STANDARD
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status Date
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          Submissions Public Notes
        5. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
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        application number
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        approval interpretation
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        1. Appl No
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          Submission Type
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
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        Sponsor Name
        MYLAN GMBH
        openfda application present
        true
        products
        1. Active Ingredient
          PEGFILGRASTIM-JMDB
          Appl No
          761075
          Drug Name
          FULPHILA
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          6MG/0.6ML
          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
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      1 INDICATIONS AND USAGE Fulphila is a leukocyte growth factor indicated to • Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically signif
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            1 INDICATIONS AND USAGE Fulphila is a leukocyte growth factor indicated to
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            1 INDICATIONS AND USAGE Fulphila is a leukocyte growth factor indicated to • Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosup
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                  • Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
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                  as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malig
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                        ( 1.1 ) Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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                        gnificant incidence of febrile neutropenia. ( 1.1 ) Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1) ] . Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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                              1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1) ] .
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                              enia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1) ] . Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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                              source field
                              indications_and_usage_exact
                              source text sha256
                              e87f0c50d635f933cf857d000a7cc3bd1476113a75fbab3a8713d461dbf3e818
                              start
                              629
                              current approval status
                              not_reconciled
                              duplicate text group
                              dup-75e70ec8c092e570b246
                              extraction review status
                              automated_candidate_pending_source_review
                              generic names
                              1. PEGFILGRASTIM-JMDB
                              id
                              ind-span-c04703222f5e47ec0a99
                              label id
                              d060dfe4-0d02-2d02-34f3-c31bfff5ab7a
                              positive predicate support span
                              Source null
                              qualifier mentions
                                regulatory links
                                  schema version
                                  0.1.0
                                  source batch sha256
                                  a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                  source defined aliases
                                    source span
                                    end
                                    976
                                    end exclusive
                                    true
                                    exact text
                                    Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
                                    label id
                                    d060dfe4-0d02-2d02-34f3-c31bfff5ab7a
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    e87f0c50d635f933cf857d000a7cc3bd1476113a75fbab3a8713d461dbf3e818
                                    start
                                    829
                                    source url
                                    https://api.fda.gov/drug/label.json?search=id%3A%22d060dfe4-0d02-2d02-34f3-c31bfff5ab7a%22
                                    spl effective date
                                    2026-01-30
                                    spl set id
                                    9bfc4d3e-6120-7fec-f1d6-0b3743752034
                                    spl version
                                    11
                                    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
                                    not_applicable

                                    Preserved source evidence · Not medical advice