LABELS · 2fc41c37-8a81-4171-a52c-e9317c0c34cf

MIMRYLO

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: 2026-08-28
Captured: 2026-09-09T23:37:42.544548+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE MIMRYLO is indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is a hepcidin mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). ( 1 )

Full extracted label fields

application numbers

NDA220605

boxed warning exact

brand names

MIMRYLO

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=101aff01-31ed-4841-a8b6-0a5a8503189b

generic names

RUSFERTIDE

2fc41c37-8a81-4171-a52c-e9317c0c34cf

indications and usage exact

1 INDICATIONS AND USAGE MIMRYLO is indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is a hepcidin mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

Takeda Pharmaceuticals America, Inc.

matched search terms

polycythemia

package ndcs

63020-715-10
63020-710-10
63020-600-05
63020-725-20
63020-720-20
63020-735-30
63020-730-30
63020-745-40
63020-740-40
63020-765-60
63020-760-60

product ndcs

63020-715
63020-725
63020-735
63020-745
63020-765

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

SUBCUTANEOUS

rxcuis

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00100.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: 100
total: 830

terms

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

sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%222fc41c37-8a81-4171-a52c-e9317c0c34cf%22

spl effective date

2026-08-28

spl effective time

20260828

spl set id

101aff01-31ed-4841-a8b6-0a5a8503189b

spl version

substance names

uniis

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled
fda_label_posted_after_spl_effective_date_requires_version_review

Drugs@FDA application source records

application number
NDA220605
payload
all indexed label documents
Appl No
220605
Application Docs Date
2026-09-01 00:00:00
Application Docs ID
87117
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220605Orig1s000lbl.pdf
Submission No
1
Submission Type
ORIG
all submission records
Appl No
220605
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2026-08-28 00:00:00
Submission Type
ORIG
Submissions Public Notes
application number
NDA220605
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=220605
has approved submission record
true
latest approved submission date
2026-08-28
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
220605
Application Docs Date
2026-09-01 00:00:00
Application Docs ID
87117
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220605Orig1s000lbl.pdf
Submission No
1
Submission Type
ORIG
official application record
Appl No
220605
Appl Public Notes
Appl Type
NDA
Sponsor Name
TAKEDA PHARMACEUTICALS U.S.A., INC.
openfda application present
true
products
Active Ingredient
RUSFERTIDE ACETATE
Appl No
220605
Drug Name
MIMRYLO
Form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product No
001
Reference Drug
0
Reference Standard
0
Strength
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

NDA220605

brand names

MIMRYLO

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: 240
end exclusive: true
exact text: 1 INDICATIONS AND USAGE MIMRYLO is indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is a hepcidin mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). ( 1 )
label id: 2fc41c37-8a81-4171-a52c-e9317c0c34cf
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 39d8aa4c428a2851319ad66da8c3ffc2c30162286e39679c439ccbc336c517ff
start: 0

current approval status

not_reconciled

duplicate text group

dup-18853b77893df9deabc9

extraction review status

automated_candidate_pending_source_review

generic names

RUSFERTIDE

ind-span-9a327a4dc19f1325ce35

label id

2fc41c37-8a81-4171-a52c-e9317c0c34cf

positive predicate support span

end: 44
end exclusive: true
exact text: is indicated
label id: 2fc41c37-8a81-4171-a52c-e9317c0c34cf
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 39d8aa4c428a2851319ad66da8c3ffc2c30162286e39679c439ccbc336c517ff
start: 32

qualifier mentions

context exact
MIMRYLO is indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV).
kind
age
polarity
not_inferred
span
end
90
end exclusive
true
exact text
adults
label id
2fc41c37-8a81-4171-a52c-e9317c0c34cf
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
39d8aa4c428a2851319ad66da8c3ffc2c30162286e39679c439ccbc336c517ff
start
84

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 119
end exclusive: true
exact text: 1 INDICATIONS AND USAGE MIMRYLO is indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV).
label id: 2fc41c37-8a81-4171-a52c-e9317c0c34cf
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 39d8aa4c428a2851319ad66da8c3ffc2c30162286e39679c439ccbc336c517ff
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%222fc41c37-8a81-4171-a52c-e9317c0c34cf%22

spl effective date

2026-08-28

spl set id

101aff01-31ed-4841-a8b6-0a5a8503189b

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 · positive indication candidate

application numbers

NDA220605

brand names

MIMRYLO

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: 240
end exclusive: true
exact text: 1 INDICATIONS AND USAGE MIMRYLO is indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is a hepcidin mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). ( 1 )
label id: 2fc41c37-8a81-4171-a52c-e9317c0c34cf
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 39d8aa4c428a2851319ad66da8c3ffc2c30162286e39679c439ccbc336c517ff
start: 0

current approval status

not_reconciled

duplicate text group

dup-70fa13a15c2b319f9e06

extraction review status

automated_candidate_pending_source_review

generic names

RUSFERTIDE

ind-span-f466b51eda121f183c4e

label id

2fc41c37-8a81-4171-a52c-e9317c0c34cf

positive predicate support span

end: 159
end exclusive: true
exact text: is a hepcidin mimetic indicated
label id: 2fc41c37-8a81-4171-a52c-e9317c0c34cf
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 39d8aa4c428a2851319ad66da8c3ffc2c30162286e39679c439ccbc336c517ff
start: 128

qualifier mentions

context exact
in mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV).
kind
age
polarity
not_inferred
span
end
205
end exclusive
true
exact text
adults
label id
2fc41c37-8a81-4171-a52c-e9317c0c34cf
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
39d8aa4c428a2851319ad66da8c3ffc2c30162286e39679c439ccbc336c517ff
start
199

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 234
end exclusive: true
exact text: MIMRYLO is a hepcidin mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV).
label id: 2fc41c37-8a81-4171-a52c-e9317c0c34cf
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 39d8aa4c428a2851319ad66da8c3ffc2c30162286e39679c439ccbc336c517ff
start: 120

source url

https://api.fda.gov/drug/label.json?search=id%3A%222fc41c37-8a81-4171-a52c-e9317c0c34cf%22

spl effective date

2026-08-28

spl set id

101aff01-31ed-4841-a8b6-0a5a8503189b

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 3 · unclassified context

application numbers

NDA220605

brand names

MIMRYLO

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 240
end exclusive: true
exact text: indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is a hepcidin mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). ( 1 )
label id: 2fc41c37-8a81-4171-a52c-e9317c0c34cf
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 39d8aa4c428a2851319ad66da8c3ffc2c30162286e39679c439ccbc336c517ff
start: 35

current approval status

not_reconciled

duplicate text group

dup-e63bc7b3df714faff0eb

extraction review status

automated_candidate_pending_source_review

generic names

RUSFERTIDE

ind-span-4888528af2dead7899a1

label id

2fc41c37-8a81-4171-a52c-e9317c0c34cf

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 240
end exclusive: true
exact text: ( 1 )
label id: 2fc41c37-8a81-4171-a52c-e9317c0c34cf
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 39d8aa4c428a2851319ad66da8c3ffc2c30162286e39679c439ccbc336c517ff
start: 235

source url

https://api.fda.gov/drug/label.json?search=id%3A%222fc41c37-8a81-4171-a52c-e9317c0c34cf%22

spl effective date

2026-08-28

spl set id

101aff01-31ed-4841-a8b6-0a5a8503189b

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