LABELS · bc6574c1-6e9f-4aee-a755-517388595ef0

RYDAPT

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: 2026-06-08
Captured: 2026-09-09T23:37:58.719708+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. ( 1.1 ) Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). ( 1.2 ) 1.1 Acute Myeloid Leukemia RYDAPT is indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, as detected by an FDA approved test [see Dosage and Administration (2.1), Clinical Studies (14.1)]. Limitations of Use RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. 1.2 Systemic Mastocytosis RYDAPT is indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

Full extracted label fields

application numbers

NDA207997

boxed warning exact

brand names

RYDAPT

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=11fa3fc9-6776-49a6-b1c1-653f627c3e58

generic names

RYDAPT

bc6574c1-6e9f-4aee-a755-517388595ef0

indications and usage exact

1 INDICATIONS AND USAGE RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. ( 1.1 ) Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). ( 1.2 ) 1.1 Acute Myeloid Leukemia RYDAPT is indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, as detected by an FDA approved test [see Dosage and Administration (2.1), Clinical Studies (14.1)]. Limitations of Use RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. 1.2 Systemic Mastocytosis RYDAPT is indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

indications and usage tables exact

is original packager

true

manufacturer names

Novartis Pharmaceuticals Corporation

matched search terms

leukemia
neoplasm
mastocytosis

package ndcs

0078-0698-02
0078-0698-51
0078-0698-99
0078-0698-19

product ndcs

0078-0698

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

1919088

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00600.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: 600
total: 830

terms

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

sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%22bc6574c1-6e9f-4aee-a755-517388595ef0%22

spl effective date

2026-06-08

spl effective time

20260608

spl set id

11fa3fc9-6776-49a6-b1c1-653f627c3e58

spl version

substance names

MIDOSTAURIN

uniis

ID912S5VON

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
NDA207997
payload
all indexed label documents
Appl No
207997
Application Docs Date
2017-04-28 00:00:00
Application Docs ID
48160
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
207997
Application Docs Date
2017-06-28 00:00:00
Application Docs ID
48161
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997Orig1Orig2s000lbl.pdf
Submission No
2
Submission Type
ORIG
Appl No
207997
Application Docs Date
2018-06-27 00:00:00
Application Docs ID
54693
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207997s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
207997
Application Docs Date
2020-03-05 00:00:00
Application Docs ID
62051
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207997s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
207997
Application Docs Date
2020-11-25 00:00:00
Application Docs ID
65334
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207997s006lbl.pdf
Submission No
6
Submission Type
SUPPL
Appl No
207997
Application Docs Date
2021-04-22 00:00:00
Application Docs ID
67151
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207997s007lbl.pdf
Submission No
7
Submission Type
SUPPL
Appl No
207997
Application Docs Date
2021-11-16 00:00:00
Application Docs ID
69322
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207997s008lbledt.pdf
Submission No
8
Submission Type
SUPPL
Appl No
207997
Application Docs Date
2023-05-23 00:00:00
Application Docs ID
74349
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207997s010lbl.pdf
Submission No
10
Submission Type
SUPPL
all submission records
Appl No
207997
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
1
Submission Status
AP
Submission Status Date
2017-04-28 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
207997
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
2
Submission Status
AP
Submission Status Date
2017-04-28 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
207997
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
2
Submission Status
AP
Submission Status Date
2018-06-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
207997
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2020-03-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
207997
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
6
Submission Status
AP
Submission Status Date
2020-11-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
207997
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
7
Submission Status
AP
Submission Status Date
2021-04-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
207997
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
8
Submission Status
AP
Submission Status Date
2021-11-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
207997
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
10
Submission Status
AP
Submission Status Date
2023-05-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA207997
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=207997
has approved submission record
true
latest approved submission date
2023-05-22
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
207997
Application Docs Date
2023-05-23 00:00:00
Application Docs ID
74349
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207997s010lbl.pdf
Submission No
10
Submission Type
SUPPL
official application record
Appl No
207997
Appl Public Notes
Appl Type
NDA
Sponsor Name
NOVARTIS
openfda application present
true
products
Active Ingredient
MIDOSTAURIN
Appl No
207997
Drug Name
RYDAPT
Form
CAPSULE;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
25MG
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

NDA207997

brand names

RYDAPT

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: 514
end exclusive: true
exact text: 1 INDICATIONS AND USAGE RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. ( 1.1 ) Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. Aggressive systemic mastocytosis (ASM), systemic mastocytosis with asso
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current approval status

not_reconciled

duplicate text group

dup-bc417c65bdfb85f9e8de

extraction review status

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generic names

RYDAPT

ind-span-fa2f3736c4c52ffee6b8

label id

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positive predicate support span

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exact text: is a kinase inhibitor indicated
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start: 31

qualifier mentions

context exact
RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed acute myeloid leukemia (AML) that is
kind
age
polarity
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span
end
98
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true
exact text
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context exact
with: Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and
kind
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exact text
FLT3 mutation-positive as detected by an FDA
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context exact
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kind
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exact text
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regulatory links

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source defined aliases

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exact text: 1 INDICATIONS AND USAGE RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
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source array index: 0
source field: indications_and_usage_exact
source text sha256: 7ffe1604b29cbcb97c30323109424a9a30f19771bbd3382aed51d8eb7c600349
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22bc6574c1-6e9f-4aee-a755-517388595ef0%22

spl effective date

2026-06-08

spl set id

11fa3fc9-6776-49a6-b1c1-653f627c3e58

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 · limitation of use

application numbers

NDA207997

brand names

RYDAPT

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 642
end exclusive: true
exact text: nosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. ( 1.1 ) Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). ( 1.2 ) 1.1 Acute Myeloid Leukemia RYDAPT is indicated in c
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start: 115

current approval status

not_reconciled

duplicate text group

dup-fff18f9adfdd15311414

extraction review status

automated_candidate_pending_source_review

generic names

RYDAPT

ind-span-3b2bdbeed81d61bf7d26

label id

bc6574c1-6e9f-4aee-a755-517388595ef0

positive predicate support span

Source null

qualifier mentions

context exact
( 1.1 ) Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.
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exact text
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regulatory links

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exact text: ( 1.1 ) Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.
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start: 315

source url

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spl effective date

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spl set id

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structured indication

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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 3 · unclassified context

application numbers

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brand names

RYDAPT

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

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content role

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context span

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end exclusive: true
exact text: ard cytarabine and daunorubicin induction and cytarabine consolidation. ( 1.1 ) Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). ( 1.2 ) 1.1 Acute Myeloid Leukemia RYDAPT is indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patient
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exact text: Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
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source url

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spl effective date

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structured indication

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

use intent

unclear

Passage 4 · unclassified context

application numbers

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brand names

RYDAPT

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clinical review status

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exact text: t induction therapy for the treatment of patients with AML. Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). ( 1.2 ) 1.1 Acute Myeloid Leukemia RYDAPT is indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with n
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exact text: ( 1.2 )
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source url

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spl effective date

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structured indication

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disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
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tumor histology: Source null

use intent

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Passage 5 · positive indication candidate

application numbers

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brand names

RYDAPT

classification reasons

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