LABELS · 23d9f1d4-c25a-45fb-8095-986c659cb532

NYPOZI txid

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: 2026-01-15
Captured: 2026-09-09T23:37:42.544548+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE NYPOZI is a leukocyte growth factor indicated to: Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) ( 1.3 ) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis ( 1.4 ) Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia ( 1.5 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) ( 1.6 ) 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NYPOZI is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1) ] . 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy NYPOZI is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2) ] . 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation NYPOZI is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3) ] . 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy NYPOZI is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4) ] . 1.5 Patients with Severe Chronic Neutropenia NYPOZI is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia [see Clinical Studies (14.5) ] . 1.6 Patients Acutely Exposed to Myelosuppressive Doses of Radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) NYPOZI is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Clinical Studies (14.6) ] .

Full extracted label fields

application numbers

BLA761126

boxed warning exact

brand names

NYPOZI txid

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89092bb8-6a20-e23e-e053-2a95a90aa750

generic names

FILGRASTIM-TXID

23d9f1d4-c25a-45fb-8095-986c659cb532

indications and usage exact

1 INDICATIONS AND USAGE NYPOZI is a leukocyte growth factor indicated to: Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) ( 1.3 ) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis ( 1.4 ) Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia ( 1.5 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) ( 1.6 ) 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NYPOZI is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1) ] . 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy NYPOZI is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2) ] . 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation NYPOZI is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3) ] . 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy NYPOZI is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4) ] . 1.5 Patients with Severe Chronic Neutropenia NYPOZI is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia [see Clinical Studies (14.5) ] . 1.6 Patients Acutely Exposed to Myelosuppressive Doses of Radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) NYPOZI is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Clinical Studies (14.6) ] .

indications and usage tables exact

is original packager

true

manufacturer names

Tanvex BioPharma USA, Inc.

matched search terms

cancer
leukemia

package ndcs

72374-101-10
72374-101-01
72374-102-01
72374-102-10

product ndcs

72374-101
72374-102

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS
SUBCUTANEOUS

rxcuis

2700369
2700376
2700378
2700379

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00100.json

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

BLA761126

brand names

NYPOZI txid

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1419
end exclusive: true
exact text: 1 INDICATIONS AND USAGE NYPOZI is a leukocyte growth factor indicated to: Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) ( 1.3 ) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis ( 1.4 ) Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia ( 1.5 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) ( 1.6 ) 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NYPOZI is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignan
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current approval status

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generic names

FILGRASTIM-TXID

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label id

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qualifier mentions

regulatory links

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source defined aliases

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exact text: 1 INDICATIONS AND USAGE NYPOZI is a leukocyte growth factor indicated to: Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) ( 1.3 ) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis ( 1.4 ) Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia ( 1.5 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) ( 1.6 )
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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

structured fields status

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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

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brand names

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classification reasons

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supportive_or_complication_use_words

clinical review status

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context span

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end exclusive: true
exact text: cyclic neutropenia‚ or idiopathic neutropenia ( 1.5 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) ( 1.6 ) 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NYPOZI is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1) ] . 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy NYPOZI is indicated for reducing the time to neutrophil recovery and the duration of fever, following induct
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generic names

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qualifier mentions

regulatory links

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source defined aliases

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exact text: 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NYPOZI is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1) ] .
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source text sha256: 7aadcff7497154a20b6451b770be5552dac3a27757d09228f6259a1ccc3574a9
start: 1220

source url

https://api.fda.gov/drug/label.json?search=id%3A%2223d9f1d4-c25a-45fb-8095-986c659cb532%22

spl effective date

2026-01-15

spl set id

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spl version

structured fields status

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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 3 · positive indication candidate

application numbers

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brand names

NYPOZI txid

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

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context span

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exact text: openia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1) ] . 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy NYPOZI is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2) ] . 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation NYPOZI is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in pati
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generic names

FILGRASTIM-TXID

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positive predicate support span

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source defined aliases

source span

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end exclusive: true
exact text: 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy NYPOZI is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2) ] .
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source url

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spl effective date

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spl set id

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spl version

structured fields status

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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 4 · positive indication candidate

application numbers

BLA761126

brand names

NYPOZI txid

classification reasons

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supportive_or_complication_use_words

clinical review status

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context span

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end exclusive: true
exact text: g the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2) ] . 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation NYPOZI is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3) ] . 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy NYPOZI is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral bl
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exact text: 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation NYPOZI is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3) ] .
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source url

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spl effective date

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limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

supportive_care_candidate

Passage 5 · positive indication candidate

application numbers

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brand names

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exact text: d clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3) ] . 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy NYPOZI is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4) ] . 1.5 Patients with Severe Chronic Neutropenia NYPOZI is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulc
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exact text: 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy NYPOZI is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4) ] .
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2223d9f1d4-c25a-45fb-8095-986c659cb532%22

spl effective date

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spl set id

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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 6 · positive indication candidate

application numbers

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brand names

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clinical review status

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exact text: Collection and Therapy NYPOZI is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4) ] . 1.5 Patients with Severe Chronic Neutropenia NYPOZI is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia [see Clinical Studies (14.5) ] . 1.6 Patients Acutely Exposed to Myelosuppressive Doses of Radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) NYPOZI is indicated to increase survival in patients acutely exposed to myelos
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current approval status

not_reconciled

duplicate text group

dup-cbfe4e8aceeb013d2618

extraction review status

automated_candidate_pending_source_review

generic names

FILGRASTIM-TXID

ind-span-d3dddc31b8eba71e14d5

label id

23d9f1d4-c25a-45fb-8095-986c659cb532

positive predicate support span

end: 2573
end exclusive: true
exact text: is indicated
label id: 23d9f1d4-c25a-45fb-8095-986c659cb532
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source field: indications_and_usage_exact
source text sha256: 7aadcff7497154a20b6451b770be5552dac3a27757d09228f6259a1ccc3574a9
start: 2561

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

source span

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exact text: 1.5 Patients with Severe Chronic Neutropenia NYPOZI is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia [see Clinical Studies (14.5) ] .
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source text sha256: 7aadcff7497154a20b6451b770be5552dac3a27757d09228f6259a1ccc3574a9
start: 2509

source url

https://api.fda.gov/drug/label.json?search=id%3A%2223d9f1d4-c25a-45fb-8095-986c659cb532%22

spl effective date

2026-01-15

spl set id

89092bb8-6a20-e23e-e053-2a95a90aa750

spl version

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 7 · positive indication candidate

application numbers

BLA761126

brand names

NYPOZI txid

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3106
end exclusive: true
exact text: elae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia [see Clinical Studies (14.5) ] . 1.6 Patients Acutely Exposed to Myelosuppressive Doses of Radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) NYPOZI is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Clinical Studies (14.6) ] .
label id: 23d9f1d4-c25a-45fb-8095-986c659cb532
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source text sha256: 7aadcff7497154a20b6451b770be5552dac3a27757d09228f6259a1ccc3574a9
start: 2645

current approval status

not_reconciled

duplicate text group

dup-86ab6276e35ac2aeee86

extraction review status

automated_candidate_pending_source_review

generic names

FILGRASTIM-TXID

ind-span-2ef65396628715b7319d

label id

23d9f1d4-c25a-45fb-8095-986c659cb532

positive predicate support span

end: 2985
end exclusive: true
exact text: is indicated
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source field: indications_and_usage_exact
source text sha256: 7aadcff7497154a20b6451b770be5552dac3a27757d09228f6259a1ccc3574a9
start: 2973

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 3106
end exclusive: true
exact text: 1.6 Patients Acutely Exposed to Myelosuppressive Doses of Radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) NYPOZI is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Clinical Studies (14.6) ] .
label id: 23d9f1d4-c25a-45fb-8095-986c659cb532
offset unit: unicode_code_points
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source text sha256: 7aadcff7497154a20b6451b770be5552dac3a27757d09228f6259a1ccc3574a9
start: 2845

source url

https://api.fda.gov/drug/label.json?search=id%3A%2223d9f1d4-c25a-45fb-8095-986c659cb532%22

spl effective date

2026-01-15

spl set id

89092bb8-6a20-e23e-e053-2a95a90aa750

spl version

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

Preserved source evidence · Not medical advice