LABELS · eaca3a36-2256-47c8-ae49-3a866c61a133

Vonjo

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: 2026-07-30
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L. This indication is approved under accelerated approval based on spleen volume reduction [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). VONJO is a kinase inhibitor indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10 9 /L ( 1 ). This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Full extracted label fields

application numbers

NDA208712

boxed warning exact

brand names

Vonjo

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4b5ab444-0e1a-4984-99db-76ad11a298ee

generic names

PACRITINIB

eaca3a36-2256-47c8-ae49-3a866c61a133

indications and usage exact

1 INDICATIONS AND USAGE VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L. This indication is approved under accelerated approval based on spleen volume reduction [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). VONJO is a kinase inhibitor indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10 9 /L ( 1 ). This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

indications and usage tables exact

is original packager

true

manufacturer names

Sobi, Inc.

matched search terms

myelofibrosis
polycythemia
thrombocythemia

package ndcs

72482-100-12

product ndcs

72482-100

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Warnings and Precautions ( 5.9 ) 11/2024 Warnings and Precautions ( 5.2 ) 08/2025 Dosage and Administration ( 2.6 ) 10/2025 Warnings and Precautions ( 5.9 ) 03/2026

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2595248
2595254

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00700.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

license

https://open.fda.gov/license/

results

limit: 100
skip: 700
total: 830

terms

https://open.fda.gov/terms/

sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%22eaca3a36-2256-47c8-ae49-3a866c61a133%22

spl effective date

2026-07-30

spl effective time

20260730

spl set id

4b5ab444-0e1a-4984-99db-76ad11a298ee

spl version

substance names

PACRITINIB

uniis

G22N65IL3O

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled

Drugs@FDA application source records

application number
NDA208712
payload
all indexed label documents
Appl No
208712
Application Docs Date
2022-07-12 00:00:00
Application Docs ID
71536
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208712s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
208712
Application Docs Date
2023-08-16 00:00:00
Application Docs ID
75090
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208712s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
208712
Application Docs Date
2024-11-14 00:00:00
Application Docs ID
80207
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208712s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
208712
Application Docs Date
2025-08-25 00:00:00
Application Docs ID
83181
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208712s006lbl.pdf
Submission No
6
Submission Type
SUPPL
Appl No
208712
Application Docs Date
2025-10-08 00:00:00
Application Docs ID
83692
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208712s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
208712
Application Docs Date
2026-03-24 00:00:00
Application Docs ID
85484
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208712s007lbl.pdf
Submission No
7
Submission Type
SUPPL
Appl No
208712
Application Docs Date
2026-07-27 00:00:00
Application Docs ID
86711
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208712s009lbl.pdf
Submission No
9
Submission Type
SUPPL
all submission records
Appl No
208712
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
9
Submission Status
AP
Submission Status Date
2026-07-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
208712
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
7
Submission Status
AP
Submission Status Date
2026-03-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
208712
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
6
Submission Status
AP
Submission Status Date
2025-08-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
208712
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2025-10-01 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
208712
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2024-11-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
208712
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
1
Submission Status
AP
Submission Status Date
2023-08-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
208712
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2022-02-28 00:00:00
Submission Type
ORIG
Submissions Public Notes
application number
NDA208712
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208712
has approved submission record
true
latest approved submission date
2026-07-20
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
Appl No
208712
Application Docs Date
2026-07-27 00:00:00
Application Docs ID
86711
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208712s009lbl.pdf
Submission No
9
Submission Type
SUPPL
official application record
Appl No
208712
Appl Public Notes
Appl Type
NDA
Sponsor Name
SOBI
openfda application present
true
products
Active Ingredient
PACRITINIB CITRATE
Appl No
208712
Drug Name
VONJO
Form
CAPSULE;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
EQ 100MG BASE
marketing status
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

NDA208712

brand names

Vonjo

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

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context span

end: 442
end exclusive: true
exact text: 1 INDICATIONS AND USAGE VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L. This indication is approved under accelerated approval based on spleen volume reduction [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and
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start: 0

current approval status

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extraction review status

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generic names

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label id

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positive predicate support span

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end exclusive: true
exact text: is indicated
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source text sha256: f095854dd7667a7df7069fcdb29d611f7eec80596935f4d33f781ab4c9d8bc10
start: 30

qualifier mentions

context exact
DICATIONS AND USAGE VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-p
kind
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span
end
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regulatory links

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exact text: 1 INDICATIONS AND USAGE VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L.
label id: eaca3a36-2256-47c8-ae49-3a866c61a133
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f095854dd7667a7df7069fcdb29d611f7eec80596935f4d33f781ab4c9d8bc10
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22eaca3a36-2256-47c8-ae49-3a866c61a133%22

spl effective date

2026-07-30

spl set id

4b5ab444-0e1a-4984-99db-76ad11a298ee

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 2 · approval contingency

application numbers

NDA208712

brand names

Vonjo

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 562
end exclusive: true
exact text: for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L. This indication is approved under accelerated approval based on spleen volume reduction [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). VONJO is a kinase inhibitor indicated for the treatment of a
label id: eaca3a36-2256-47c8-ae49-3a866c61a133
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f095854dd7667a7df7069fcdb29d611f7eec80596935f4d33f781ab4c9d8bc10
start: 43

current approval status

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duplicate text group

dup-3fc56cffa020971ee59e

extraction review status

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generic names

PACRITINIB

ind-span-5f70c1c826720683b538

label id

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positive predicate support span

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source defined aliases

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exact text: This indication is approved under accelerated approval based on spleen volume reduction [see Clinical Studies ( 14 )] .
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source array index: 0
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start: 243

source url

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spl effective date

2026-07-30

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

not_applicable

Passage 3 · approval contingency

application numbers

NDA208712

brand names

Vonjo

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 701
end exclusive: true
exact text: l thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L. This indication is approved under accelerated approval based on spleen volume reduction [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). VONJO is a kinase inhibitor indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a p
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start: 163

current approval status

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duplicate text group

dup-da720a68032e3fe20d79

extraction review status

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generic names

PACRITINIB

ind-span-f58400872212ce446468

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positive predicate support span

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exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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start: 363

source url

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spl effective date

2026-07-30

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

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Passage 4 · positive indication candidate

application numbers

NDA208712

brand names

Vonjo

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

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context span

end: 940
end exclusive: true
exact text: d on spleen volume reduction [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). VONJO is a kinase inhibitor indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10 9 /L ( 1 ). This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit
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current approval status

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qualifier mentions

context exact
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exact text: VONJO is a kinase inhibitor indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10 9 /L ( 1 ).
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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
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 5 · approval contingency

application numbers

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brand names

Vonjo

classification reasons

approval_contingency_words

clinical review status

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context span

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end exclusive: true
exact text: or the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10 9 /L ( 1 ). This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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start: 541

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exact text: This indication is approved under accelerated approval based on spleen volume reduction.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22eaca3a36-2256-47c8-ae49-3a866c61a133%22

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

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Passage 6 · approval contingency

application numbers

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brand names

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approval_contingency_words

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end: 968
end exclusive: true
exact text: cythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10 9 /L ( 1 ). This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
label id: eaca3a36-2256-47c8-ae49-3a866c61a133
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f095854dd7667a7df7069fcdb29d611f7eec80596935f4d33f781ab4c9d8bc10
start: 630

current approval status

not_reconciled

duplicate text group

dup-da720a68032e3fe20d79

extraction review status

automated_candidate_pending_source_review

generic names

PACRITINIB

ind-span-07707b411ad8b6f56931

label id

eaca3a36-2256-47c8-ae49-3a866c61a133

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 968
end exclusive: true
exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
label id: eaca3a36-2256-47c8-ae49-3a866c61a133
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f095854dd7667a7df7069fcdb29d611f7eec80596935f4d33f781ab4c9d8bc10
start: 830

source url

https://api.fda.gov/drug/label.json?search=id%3A%22eaca3a36-2256-47c8-ae49-3a866c61a133%22

spl effective date

2026-07-30

spl set id

4b5ab444-0e1a-4984-99db-76ad11a298ee

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

not_applicable

Preserved source evidence · Not medical advice