LABELS · 8bee41f8-a2d9-44ae-82a9-bd46b6f9916a

OJEMDA

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: 2025-09-02
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. ( 1 ) This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14) ]. 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

NDA217700
NDA218033

boxed warning exact

brand names

OJEMDA

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea3a9631-3a66-6a7c-e053-2995a90ae2ad

generic names

TOVORAFENIB

8bee41f8-a2d9-44ae-82a9-bd46b6f9916a

indications and usage exact

1 INDICATIONS AND USAGE OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. ( 1 ) This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14) ]. 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

Day One Biopharmaceuticals, Inc.

matched search terms

glioma

package ndcs

82950-012-01
82950-112-10
82950-001-06
82950-001-24
82950-001-05
82950-001-20
82950-001-04
82950-001-16

product ndcs

82950-001
82950-012

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Dosage and Administration ( 2.1 ) 08/2025 Warnings and Precautions ( 5.4 ) 08/2025

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2682439
2682445
2682450
2682454
2690857
2690858
2690859
2690860
2690861
2690862

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00500.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: 500
total: 830

terms

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

sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%228bee41f8-a2d9-44ae-82a9-bd46b6f9916a%22

spl effective date

2025-09-02

spl effective time

20250902

spl set id

ea3a9631-3a66-6a7c-e053-2995a90ae2ad

spl version

substance names

TOVORAFENIB

uniis

ZN90E4027M

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
NDA217700
payload
all indexed label documents
Appl No
217700
Application Docs Date
2024-05-22 00:00:00
Application Docs ID
78536
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
217700
Application Docs Date
2024-06-27 00:00:00
Application Docs ID
78918
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s001,218033s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
217700
Application Docs Date
2025-08-28 00:00:00
Application Docs ID
83217
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217700s002s003s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
217700
Application Docs Date
2025-08-28 00:00:00
Application Docs ID
83218
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217700s002s003s004lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
217700
Application Docs Date
2025-08-28 00:00:00
Application Docs ID
83219
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217700s002s003s004lbl.pdf
Submission No
2
Submission Type
SUPPL
all submission records
Appl No
217700
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2024-04-23 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
217700
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
1
Submission Status
AP
Submission Status Date
2024-06-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
217700
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
2
Submission Status
AP
Submission Status Date
2025-08-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
217700
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2025-08-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
217700
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2025-08-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA217700
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=217700
has approved submission record
true
latest approved submission date
2025-08-27
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
217700
Application Docs Date
2025-08-28 00:00:00
Application Docs ID
83217
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217700s002s003s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
217700
Application Docs Date
2025-08-28 00:00:00
Application Docs ID
83218
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217700s002s003s004lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
217700
Application Docs Date
2025-08-28 00:00:00
Application Docs ID
83219
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217700s002s003s004lbl.pdf
Submission No
2
Submission Type
SUPPL
official application record
Appl No
217700
Appl Public Notes
Appl Type
NDA
Sponsor Name
DAY ONE BIOPHARMS
openfda application present
true
products
Active Ingredient
TOVORAFENIB
Appl No
217700
Drug Name
OJEMDA
Form
TABLET;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
100MG
marketing status
Prescription
application number
NDA218033
payload
all indexed label documents
Appl No
218033
Application Docs Date
2024-05-22 00:00:00
Application Docs ID
78538
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218033s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
218033
Application Docs Date
2024-06-27 00:00:00
Application Docs ID
78919
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s001,218033s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
218033
Application Docs Date
2025-08-28 00:00:00
Application Docs ID
83220
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218033s002s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
218033
Application Docs Date
2025-08-28 00:00:00
Application Docs ID
83221
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218033s002s003lbl.pdf
Submission No
2
Submission Type
SUPPL
all submission records
Appl No
218033
Review Priority
PRIORITY
Submission Class Code ID
12
Submission No
1
Submission Status
AP
Submission Status Date
2024-04-23 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
218033
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
1
Submission Status
AP
Submission Status Date
2024-06-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
218033
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
2
Submission Status
AP
Submission Status Date
2025-08-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
218033
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2025-08-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA218033
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=218033
has approved submission record
true
latest approved submission date
2025-08-27
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
218033
Application Docs Date
2025-08-28 00:00:00
Application Docs ID
83220
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218033s002s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
218033
Application Docs Date
2025-08-28 00:00:00
Application Docs ID
83221
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218033s002s003lbl.pdf
Submission No
2
Submission Type
SUPPL
official application record
Appl No
218033
Appl Public Notes
Appl Type
NDA
Sponsor Name
DAY ONE BIOPHARMS
openfda application present
true
products
Active Ingredient
TOVORAFENIB
Appl No
218033
Drug Name
OJEMDA
Form
FOR SUSPENSION;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
25MG/ML
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

NDA217700
NDA218033

brand names

OJEMDA

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 425
end exclusive: true
exact text: 1 INDICATIONS AND USAGE OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon veri
label id: 8bee41f8-a2d9-44ae-82a9-bd46b6f9916a
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source array index: 0
source field: indications_and_usage_exact
source text sha256: 689269789a612342cfa121785015ded55d2d311d0fccaeb16b8024affce2b85b
start: 0

current approval status

not_reconciled

duplicate text group

dup-ce9ef5ccdc85aeefcc8c

extraction review status

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generic names

TOVORAFENIB

ind-span-b1c6ac39d0e0b84a2d4a

label id

8bee41f8-a2d9-44ae-82a9-bd46b6f9916a

positive predicate support span

end: 43
end exclusive: true
exact text: is indicated
label id: 8bee41f8-a2d9-44ae-82a9-bd46b6f9916a
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source text sha256: 689269789a612342cfa121785015ded55d2d311d0fccaeb16b8024affce2b85b
start: 31

qualifier mentions

context exact
ients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrange
kind
age
polarity
not_inferred
span
end
137
end exclusive
true
exact text
pediatric
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source text sha256
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context exact
or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
kind
biomarker
polarity
not_inferred
span
end
201
end exclusive
true
exact text
BRAF fusion or rearrangement
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context exact
e glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
kind
biomarker
polarity
not_inferred
span
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end exclusive
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exact text
BRAF V600 mutation
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source field
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source text sha256
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start
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context exact
or the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BR
kind
stage_or_setting
polarity
not_inferred
span
end
148
end exclusive
true
exact text
relapsed or refractory pediatric low-grade
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start
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regulatory links

candidate source span
end
225
end exclusive
true
exact text
1 INDICATIONS AND USAGE OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
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indications_and_usage_exact
source text sha256
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start
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fda indication exact
Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
fda source row index
23
fda source sha256
8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
fda status record id
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interpretation
Source wording correspondence to a dated FDA status row; current approval not certified
match method
whole_indication_literal_normalized_substring
matching review status
source_comparison_only_clinical_review_pending
scope relationship
whole_fda_indication_text_present
source url
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exact text: 1 INDICATIONS AND USAGE OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%228bee41f8-a2d9-44ae-82a9-bd46b6f9916a%22

spl effective date

2025-09-02

spl set id

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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

Read indication-specific status → · whole_fda_indication_text_present

Passage 2 · approval contingency

application numbers

NDA217700
NDA218033

brand names

OJEMDA

classification reasons

approval_contingency_words

clinical review status

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approval_contingency

context span

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exact text: EMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). OJEMDA is a kinase inhibitor indicated for the treatment of
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current approval status

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generic names

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exact text: This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14) ].
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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

not_applicable

Passage 3 · approval contingency

application numbers

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NDA218033

brand names

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classification reasons

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clinical review status

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context span

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exact text: ) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, o
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current approval status

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generic names

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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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source array index: 0
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Passage 4 · positive indication candidate

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exact text: rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. ( 1 ) This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upo
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OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
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fda indication exact
Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
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exact text: OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
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Read indication-specific status → · whole_fda_indication_text_present

Passage 5 · approval contingency

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Passage 6 · approval contingency

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Preserved source evidence · Not medical advice