LABELS · b5e85656-77f8-405d-982e-c3d890a0f99b

ZEJULA

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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: 2026-07-28
Captured: 2026-09-09T23:37:58.719708+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: • for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.1 , 2.1 ) • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.2 , 2.1 ) 1.1 First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer ZEJULA is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: • a deleterious or suspected deleterious BRCA mutation, and/or • genomic instability. Select patients for therapy based on an FDA ‑ authorized companion diagnostic for ZEJULA [see Dosage and Administration ( 2.1 )] . 1.2 Maintenance Treatment of Recurrent Germline BRCA -Mutated Ovarian Cancer ZEJULA is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA mut) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA [see Dosage and Administration ( 2.1 )] .

Full extracted label fields

application numbers

NDA214876

boxed warning exact

brand names

ZEJULA

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7f675e2-159c-490c-b6f4-3f16d9492b7d

generic names

NIRAPARIB

b5e85656-77f8-405d-982e-c3d890a0f99b

indications and usage exact

1 INDICATIONS AND USAGE ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: • for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.1 , 2.1 ) • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.2 , 2.1 ) 1.1 First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer ZEJULA is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: • a deleterious or suspected deleterious BRCA mutation, and/or • genomic instability. Select patients for therapy based on an FDA ‑ authorized companion diagnostic for ZEJULA [see Dosage and Administration ( 2.1 )] . 1.2 Maintenance Treatment of Recurrent Germline BRCA -Mutated Ovarian Cancer ZEJULA is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA mut) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA [see Dosage and Administration ( 2.1 )] .

indications and usage tables exact

is original packager

true

manufacturer names

GlaxoSmithKline LLC

matched search terms

cancer

package ndcs

0173-0909-13
0173-0912-13
0173-0912-61
0173-0915-13
0173-0915-61

product ndcs

0173-0909
0173-0912
0173-0915

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage ( 1.1 ) 3/2026 Dosage and Administration ( 2.1 ) 3/2026

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

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2637452
2637465
2640210
2640212
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source batch

file

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Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · indication intro context

application numbers

NDA214876

brand names

ZEJULA

classification reasons

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exact text: 1 INDICATIONS AND USAGE ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: • for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based
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qualifier mentions

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exact text: 1 INDICATIONS AND USAGE ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
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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

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approval pathway: Source null
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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

Passage 2 · positive indication candidate

application numbers

NDA214876

brand names

ZEJULA

classification reasons

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exact text: 1 INDICATIONS AND USAGE ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: • for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.1 , 2.1 ) • for the maintenance treatment of adult patients with deleterious or suspected deleterious germl
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qualifier mentions

context exact
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exact text
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context exact
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context exact
itoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic insta
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exact text: • for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability.
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source url

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spl effective date

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structured indication

age: Source null
approval pathway: Source null
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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

NDA214876

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ZEJULA

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exact text: and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.1 , 2.1 ) • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal ca
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source url

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spl effective date

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structured indication

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

use intent

unclear

Passage 4 · unclassified context

application numbers

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ZEJULA

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exact text: status defined by either: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.1 , 2.1 ) • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are i
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source url

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Passage 5 · positive indication candidate

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ZEJULA

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exact text: by either: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.1 , 2.1 ) • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.2 , 2.1 ) 1.1 First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer ZEJULA is indicated
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exact text: • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
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source url

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tumor histology: Source null

use intent

tumor_directed_candidate

Passage 6 · unclassified context

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exact text: us or suspected deleterious germline BRCA -mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.2 , 2.1 ) 1.1 First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer ZEJULA is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallop
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source defined aliases

source span

end: 1982
end exclusive: true
exact text: 1.2 Maintenance Treatment of Recurrent Germline BRCA -Mutated Ovarian Cancer ZEJULA is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA mut) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
label id: b5e85656-77f8-405d-982e-c3d890a0f99b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d7a1dc7ffdfaddc7b4bf4fa6780a64f6a44a540c799f4490b6c2504d58fc9360
start: 1611

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b5e85656-77f8-405d-982e-c3d890a0f99b%22

spl effective date

2026-07-28

spl set id

b7f675e2-159c-490c-b6f4-3f16d9492b7d

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

tumor_directed_candidate

Passage 13 · unclassified context

application numbers

NDA214876

brand names

ZEJULA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2111
end exclusive: true
exact text: ed deleterious germline BRCA -mutated (g BRCA mut) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA [see Dosage and Administration ( 2.1 )] .
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source text sha256: d7a1dc7ffdfaddc7b4bf4fa6780a64f6a44a540c799f4490b6c2504d58fc9360
start: 1783

current approval status

not_reconciled

duplicate text group

dup-d659c3f6ed46fab9a721

extraction review status

automated_candidate_pending_source_review

generic names

NIRAPARIB

ind-span-b39ed59fc32b65d0bbe8

label id

b5e85656-77f8-405d-982e-c3d890a0f99b

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: 2111
end exclusive: true
exact text: Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA [see Dosage and Administration ( 2.1 )] .
label id: b5e85656-77f8-405d-982e-c3d890a0f99b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d7a1dc7ffdfaddc7b4bf4fa6780a64f6a44a540c799f4490b6c2504d58fc9360
start: 1983

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b5e85656-77f8-405d-982e-c3d890a0f99b%22

spl effective date

2026-07-28

spl set id

b7f675e2-159c-490c-b6f4-3f16d9492b7d

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

unclear

Preserved source evidence · Not medical advice