LABELS · 67cbcafa-00b3-41fd-986d-1159706273f3

POSLUMA

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: 2026-07-25
Captured: 2026-09-09T23:37:51.659493+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. POSLUMA is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. ( 1 )

Full extracted label fields

application numbers

NDA216023

boxed warning exact

brand names

POSLUMA

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=907ac4a4-a088-4826-ab50-cfc31985c9d4

generic names

FLOTUFOLASTAT F-18

67cbcafa-00b3-41fd-986d-1159706273f3

indications and usage exact

1 INDICATIONS AND USAGE POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. POSLUMA is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

Blue Earth Diagnostics

matched search terms

cancer

package ndcs

69932-002-50

product ndcs

69932-002

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00400.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: 400
total: 830

terms

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

sha256

a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%2267cbcafa-00b3-41fd-986d-1159706273f3%22

spl effective date

2026-07-25

spl effective time

20260725

spl set id

907ac4a4-a088-4826-ab50-cfc31985c9d4

spl version

substance names

FLOTUFOLASTAT F-18

uniis

811W19E3OL

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
NDA216023
payload
all indexed label documents
Appl No
216023
Application Docs Date
2023-05-26 00:00:00
Application Docs ID
74386
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216023s000lbl.pdf
Submission No
1
Submission Type
ORIG
all submission records
Appl No
216023
Review Priority
STANDARD
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2023-05-25 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
216023
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
4
Submission Status
AP
Submission Status Date
2025-01-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA216023
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=216023
has approved submission record
true
latest approved submission date
2025-01-10
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
216023
Application Docs Date
2023-05-26 00:00:00
Application Docs ID
74386
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216023s000lbl.pdf
Submission No
1
Submission Type
ORIG
official application record
Appl No
216023
Appl Public Notes
Appl Type
NDA
Sponsor Name
BLUE EARTH
openfda application present
true
products
Active Ingredient
FLOTUFOLASTAT F-18 GALLIUM
Appl No
216023
Drug Name
POSLUMA
Form
SOLUTION;INTRAVENOUS
Product No
001
Reference Drug
1
Reference Standard
1
Strength
25ML (8-158mCi/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

NDA216023

brand names

POSLUMA

classification reasons

explicit_positive_indication_predicate
diagnostic_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 539
end exclusive: true
exact text: 1 INDICATIONS AND USAGE POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. POSLUMA is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected me
label id: 67cbcafa-00b3-41fd-986d-1159706273f3
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current approval status

not_reconciled

duplicate text group

dup-effd8efc62b26c56b3e8

extraction review status

automated_candidate_pending_source_review

generic names

FLOTUFOLASTAT F-18

ind-span-e2eb3d5a73143e41e167

label id

67cbcafa-00b3-41fd-986d-1159706273f3

positive predicate support span

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end exclusive: true
exact text: is indicated
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source array index: 0
source field: indications_and_usage_exact
source text sha256: c08676df9130274b25da837c63b444f95d1550e59edc254c1897bda1a9d68a16
start: 32

qualifier mentions

context exact
ion tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for init
kind
biomarker
polarity
not_inferred
span
end
167
end exclusive
true
exact text
PSMA) positive lesions in men with prostate
label id
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source array index
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source field
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source text sha256
c08676df9130274b25da837c63b444f95d1550e59edc254c1897bda1a9d68a16
start
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context exact
positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevat
kind
biomarker
polarity
not_inferred
span
end
232
end exclusive
true
exact text
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source text sha256
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start
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regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

source span

end: 339
end exclusive: true
exact text: 1 INDICATIONS AND USAGE POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
label id: 67cbcafa-00b3-41fd-986d-1159706273f3
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c08676df9130274b25da837c63b444f95d1550e59edc254c1897bda1a9d68a16
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2267cbcafa-00b3-41fd-986d-1159706273f3%22

spl effective date

2026-07-25

spl set id

907ac4a4-a088-4826-ab50-cfc31985c9d4

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

diagnostic_candidate

Passage 2 · positive indication candidate

application numbers

NDA216023

brand names

POSLUMA

classification reasons

explicit_positive_indication_predicate
diagnostic_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 692
end exclusive: true
exact text: sions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. POSLUMA is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. ( 1 )
label id: 67cbcafa-00b3-41fd-986d-1159706273f3
offset unit: unicode_code_points
source array index: 0
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source text sha256: c08676df9130274b25da837c63b444f95d1550e59edc254c1897bda1a9d68a16
start: 140

current approval status

not_reconciled

duplicate text group

dup-f7f756bd69f2141edba6

extraction review status

automated_candidate_pending_source_review

generic names

FLOTUFOLASTAT F-18

ind-span-930f8c192fc7b9c59e61

label id

67cbcafa-00b3-41fd-986d-1159706273f3

positive predicate support span

end: 391
end exclusive: true
exact text: is a radioactive diagnostic agent indicated
label id: 67cbcafa-00b3-41fd-986d-1159706273f3
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c08676df9130274b25da837c63b444f95d1550e59edc254c1897bda1a9d68a16
start: 348

qualifier mentions

context exact
ion tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for ini
kind
biomarker
polarity
not_inferred
span
end
514
end exclusive
true
exact text
PSMA) positive lesions in men with prostate
label id
67cbcafa-00b3-41fd-986d-1159706273f3
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c08676df9130274b25da837c63b444f95d1550e59edc254c1897bda1a9d68a16
start
470
context exact
ositive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevate
kind
biomarker
polarity
not_inferred
span
end
580
end exclusive
true
exact text
metastasis who are candidates for initial d
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67cbcafa-00b3-41fd-986d-1159706273f3
offset unit
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source array index
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source field
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source text sha256
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start
537

regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

source span

end: 686
end exclusive: true
exact text: POSLUMA is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
label id: 67cbcafa-00b3-41fd-986d-1159706273f3
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c08676df9130274b25da837c63b444f95d1550e59edc254c1897bda1a9d68a16
start: 340

source url

https://api.fda.gov/drug/label.json?search=id%3A%2267cbcafa-00b3-41fd-986d-1159706273f3%22

spl effective date

2026-07-25

spl set id

907ac4a4-a088-4826-ab50-cfc31985c9d4

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

diagnostic_candidate

Passage 3 · unclassified context

application numbers

NDA216023

brand names

POSLUMA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 692
end exclusive: true
exact text: sions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. ( 1 )
label id: 67cbcafa-00b3-41fd-986d-1159706273f3
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c08676df9130274b25da837c63b444f95d1550e59edc254c1897bda1a9d68a16
start: 487

current approval status

not_reconciled

duplicate text group

dup-052275a278f052c0d6c8

extraction review status

automated_candidate_pending_source_review

generic names

FLOTUFOLASTAT F-18

ind-span-07c976bf45461d5c592f

label id

67cbcafa-00b3-41fd-986d-1159706273f3

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

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source batch sha256

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source defined aliases

source span

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end exclusive: true
exact text: ( 1 )
label id: 67cbcafa-00b3-41fd-986d-1159706273f3
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source field: indications_and_usage_exact
source text sha256: c08676df9130274b25da837c63b444f95d1550e59edc254c1897bda1a9d68a16
start: 687

source url

https://api.fda.gov/drug/label.json?search=id%3A%2267cbcafa-00b3-41fd-986d-1159706273f3%22

spl effective date

2026-07-25

spl set id

907ac4a4-a088-4826-ab50-cfc31985c9d4

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