LABELS · db2acb00-3e3b-4ecc-b532-08e456075404

PYLARIFY

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: 2026-02-18
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE PYLARIFY 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. PYLARIFY 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

NDA214793

boxed warning exact

brand names

PYLARIFY

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a00e5cbc-4fd5-4280-82ec-cd3498df4553

generic names

PIFLUFOLASTAT F-18

db2acb00-3e3b-4ecc-b532-08e456075404

indications and usage exact

1 INDICATIONS AND USAGE PYLARIFY 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. PYLARIFY 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

Progenics Pharmaceuticals, Inc.

matched search terms

cancer

package ndcs

71258-022-01

product ndcs

71258-022

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-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%22db2acb00-3e3b-4ecc-b532-08e456075404%22

spl effective date

2026-02-18

spl effective time

20260218

spl set id

a00e5cbc-4fd5-4280-82ec-cd3498df4553

spl version

substance names

PIFLUFOLASTAT F-18

uniis

3934EF02T7

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
NDA214793
payload
all indexed label documents
Appl No
214793
Application Docs Date
2021-05-27 00:00:00
Application Docs ID
67608
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214793s000lbl.pdf
Submission No
1
Submission Type
ORIG
all submission records
Appl No
214793
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2021-05-26 00:00:00
Submission Type
ORIG
Submissions Public Notes
application number
NDA214793
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=214793
has approved submission record
true
latest approved submission date
2021-05-26
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
214793
Application Docs Date
2021-05-27 00:00:00
Application Docs ID
67608
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214793s000lbl.pdf
Submission No
1
Submission Type
ORIG
official application record
Appl No
214793
Appl Public Notes
Appl Type
NDA
Sponsor Name
PROGENICS PHARMS INC
openfda application present
true
products
Active Ingredient
PIFLUFOLASTAT F-18
Appl No
214793
Drug Name
PYLARIFY
Form
SOLUTION;INTRAVENOUS
Product No
001
Reference Drug
1
Reference Standard
1
Strength
50ML (1-80mCi/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

NDA214793

brand names

PYLARIFY

classification reasons

explicit_positive_indication_predicate
diagnostic_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 541
end exclusive: true
exact text: 1 INDICATIONS AND USAGE PYLARIFY 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. PYLARIFY 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 m
label id: db2acb00-3e3b-4ecc-b532-08e456075404
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ef5dbf70f179f275da8e0f42f2cc9a8651b03b56fc97284e2e8b6b168eb09564
start: 0

current approval status

not_reconciled

duplicate text group

dup-37f96afd9a8fcaa261e8

extraction review status

automated_candidate_pending_source_review

generic names

PIFLUFOLASTAT F-18

ind-span-76c011d18221b926958c

label id

db2acb00-3e3b-4ecc-b532-08e456075404

positive predicate support span

end: 45
end exclusive: true
exact text: is indicated
label id: db2acb00-3e3b-4ecc-b532-08e456075404
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ef5dbf70f179f275da8e0f42f2cc9a8651b03b56fc97284e2e8b6b168eb09564
start: 33

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
168
end exclusive
true
exact text
PSMA) positive lesions in men with prostate
label id
db2acb00-3e3b-4ecc-b532-08e456075404
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ef5dbf70f179f275da8e0f42f2cc9a8651b03b56fc97284e2e8b6b168eb09564
start
124
context exact
ositive 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
234
end exclusive
true
exact text
metastasis who are candidates for initial d
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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
191

regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

source span

end: 341
end exclusive: true
exact text: 1 INDICATIONS AND USAGE PYLARIFY 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: db2acb00-3e3b-4ecc-b532-08e456075404
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ef5dbf70f179f275da8e0f42f2cc9a8651b03b56fc97284e2e8b6b168eb09564
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22db2acb00-3e3b-4ecc-b532-08e456075404%22

spl effective date

2026-02-18

spl set id

a00e5cbc-4fd5-4280-82ec-cd3498df4553

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

NDA214793

brand names

PYLARIFY

classification reasons

explicit_positive_indication_predicate
diagnostic_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 696
end exclusive: true
exact text: ions 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. PYLARIFY 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: db2acb00-3e3b-4ecc-b532-08e456075404
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ef5dbf70f179f275da8e0f42f2cc9a8651b03b56fc97284e2e8b6b168eb09564
start: 142

current approval status

not_reconciled

duplicate text group

dup-8f1171f649429ac6a1f2

extraction review status

automated_candidate_pending_source_review

generic names

PIFLUFOLASTAT F-18

ind-span-3b8eafff141206aa22f5

label id

db2acb00-3e3b-4ecc-b532-08e456075404

positive predicate support span

end: 394
end exclusive: true
exact text: is a radioactive diagnostic agent indicated
label id: db2acb00-3e3b-4ecc-b532-08e456075404
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ef5dbf70f179f275da8e0f42f2cc9a8651b03b56fc97284e2e8b6b168eb09564
start: 351

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
517
end exclusive
true
exact text
PSMA) positive lesions in men with prostate
label id
db2acb00-3e3b-4ecc-b532-08e456075404
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ef5dbf70f179f275da8e0f42f2cc9a8651b03b56fc97284e2e8b6b168eb09564
start
473
context exact
ositive 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
583
end exclusive
true
exact text
metastasis who are candidates for initial d
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db2acb00-3e3b-4ecc-b532-08e456075404
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
540

regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

source span

end: 690
end exclusive: true
exact text: PYLARIFY 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: db2acb00-3e3b-4ecc-b532-08e456075404
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ef5dbf70f179f275da8e0f42f2cc9a8651b03b56fc97284e2e8b6b168eb09564
start: 342

source url

https://api.fda.gov/drug/label.json?search=id%3A%22db2acb00-3e3b-4ecc-b532-08e456075404%22

spl effective date

2026-02-18

spl set id

a00e5cbc-4fd5-4280-82ec-cd3498df4553

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

NDA214793

brand names

PYLARIFY

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 696
end exclusive: true
exact text: ions 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: db2acb00-3e3b-4ecc-b532-08e456075404
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ef5dbf70f179f275da8e0f42f2cc9a8651b03b56fc97284e2e8b6b168eb09564
start: 491

current approval status

not_reconciled

duplicate text group

dup-c5cea0bebab67803582e

extraction review status

automated_candidate_pending_source_review

generic names

PIFLUFOLASTAT F-18

ind-span-8e9e483e7689d6b68755

label id

db2acb00-3e3b-4ecc-b532-08e456075404

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

source span

end: 696
end exclusive: true
exact text: ( 1 )
label id: db2acb00-3e3b-4ecc-b532-08e456075404
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ef5dbf70f179f275da8e0f42f2cc9a8651b03b56fc97284e2e8b6b168eb09564
start: 691

source url

https://api.fda.gov/drug/label.json?search=id%3A%22db2acb00-3e3b-4ecc-b532-08e456075404%22

spl effective date

2026-02-18

spl set id

a00e5cbc-4fd5-4280-82ec-cd3498df4553

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