LABELS · 56f3be9c-a86f-4ce5-9e52-e9e57fb95464

ILLUCCIX

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: 2026-06-15
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE ILLUCCIX, after radiolabeling with Ga 68, 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 For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ILLUCCIX, after radiolabeling with Ga 68, 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 For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ( 1 )

Full extracted label fields

application numbers

NDA214032

boxed warning exact

brand names

ILLUCCIX

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d4643b31-9b4f-673f-e053-2a95a90a559d

generic names

KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION

56f3be9c-a86f-4ce5-9e52-e9e57fb95464

indications and usage exact

1 INDICATIONS AND USAGE ILLUCCIX, after radiolabeling with Ga 68, 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 For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ILLUCCIX, after radiolabeling with Ga 68, 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 For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

Telix Pharmaceuticals (US) Inc.

matched search terms

cancer

package ndcs

74725-100-25
74725-100-64
74725-101-25
74725-102-25
74725-103-64

product ndcs

74725-100

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage ( 1 ) 9/2025 Dosage and Administration, 9/2025 General Instructions for Drug Preparation ( 2.4 ) Image Interpretation ( 2.11 ) Dosage and Administration, 1/2026 General Instructions for Drug Preparation ( 2.4 ) Preparation with Cyclotron-Produced Ga 68 via GE FASTlab Liquid Target System ( 2.5 ) Preparation with EZAG GalliaPharm Generator ( 2.6 ) Preparation with Cyclotron-Produced Ga 68 via ARTMS QIS Solid Target System ( 2.7 ) Preparation with IRE ELiT Galli Eo Generator ( 2.8 ) Specifications and Quality Control ( 2.9 ) Warnings and Precautions, Risk for Misinterpretation ( 5.1 ) 9/2025

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00300.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: 300
total: 830

terms

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

sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%2256f3be9c-a86f-4ce5-9e52-e9e57fb95464%22

spl effective date

2026-06-15

spl effective time

20260615

spl set id

d4643b31-9b4f-673f-e053-2a95a90a559d

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

Drugs@FDA application source records

application number
NDA214032
payload
all indexed label documents
Appl No
214032
Application Docs Date
2023-03-16 00:00:00
Application Docs ID
73776
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214032s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
214032
Application Docs Date
2025-09-12 00:00:00
Application Docs ID
83346
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214032s014lbl.pdf
Submission No
14
Submission Type
SUPPL
Appl No
214032
Application Docs Date
2025-12-15 00:00:00
Application Docs ID
84418
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214032s018lbl.pdf
Submission No
18
Submission Type
SUPPL
all submission records
Appl No
214032
Review Priority
STANDARD
Submission Class Code ID
13
Submission No
1
Submission Status
AP
Submission Status Date
2021-12-17 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
214032
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
1
Submission Status
AP
Submission Status Date
2023-03-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
214032
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
14
Submission Status
AP
Submission Status Date
2025-09-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
214032
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
18
Submission Status
AP
Submission Status Date
2025-12-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA214032
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=214032
has approved submission record
true
latest approved submission date
2025-12-05
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
214032
Application Docs Date
2025-12-15 00:00:00
Application Docs ID
84418
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214032s018lbl.pdf
Submission No
18
Submission Type
SUPPL
official application record
Appl No
214032
Appl Public Notes
Appl Type
NDA
Sponsor Name
TELIX
openfda application present
true
products
Active Ingredient
GALLIUM GA-68 GOZETOTIDE
Appl No
214032
Drug Name
ILLUCCIX
Form
POWDER;INTRAVENOUS
Product No
001
Reference Drug
1
Reference Standard
1
Strength
N/A
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

NDA214032

brand names

ILLUCCIX

classification reasons

explicit_positive_indication_predicate
diagnostic_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1042
end exclusive: true
exact text: 1 INDICATIONS AND USAGE ILLUCCIX, after radiolabeling with Ga 68, 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 For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ILLUCCIX, after radiolabeling with Ga 68, 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 For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ( 1 )
label id: 56f3be9c-a86f-4ce5-9e52-e9e57fb95464
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: e0d1d01071505b14ba25492ff0b547560ea8262113f9e85e10359cdecea6760e
start: 0

current approval status

not_reconciled

duplicate text group

dup-1f61e955eb3505bba950

extraction review status

automated_candidate_pending_source_review

generic names

KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION

ind-span-2805d77b277d5a0e7bd4

label id

56f3be9c-a86f-4ce5-9e52-e9e57fb95464

positive predicate support span

end: 78
end exclusive: true
exact text: is indicated
label id: 56f3be9c-a86f-4ce5-9e52-e9e57fb95464
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: e0d1d01071505b14ba25492ff0b547560ea8262113f9e85e10359cdecea6760e
start: 66

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
201
end exclusive
true
exact text
PSMA) positive lesions in men with prostate
label id
56f3be9c-a86f-4ce5-9e52-e9e57fb95464
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
e0d1d01071505b14ba25492ff0b547560ea8262113f9e85e10359cdecea6760e
start
157
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
267
end exclusive
true
exact text
metastasis who are candidates for initial d
label id
56f3be9c-a86f-4ce5-9e52-e9e57fb95464
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
e0d1d01071505b14ba25492ff0b547560ea8262113f9e85e10359cdecea6760e
start
224
context exact
(PSA) level For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ILLUCCIX,
kind
biomarker
polarity
not_inferred
span
end
465
end exclusive
true
exact text
PSMA-directed therapy as described in the pr
label id
56f3be9c-a86f-4ce5-9e52-e9e57fb95464
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
e0d1d01071505b14ba25492ff0b547560ea8262113f9e85e10359cdecea6760e
start
421
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
723
end exclusive
true
exact text
PSMA) positive lesions in men with prostate
label id
56f3be9c-a86f-4ce5-9e52-e9e57fb95464
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
e0d1d01071505b14ba25492ff0b547560ea8262113f9e85e10359cdecea6760e
start
679
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
789
end exclusive
true
exact text
metastasis who are candidates for initial d
label id
56f3be9c-a86f-4ce5-9e52-e9e57fb95464
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
e0d1d01071505b14ba25492ff0b547560ea8262113f9e85e10359cdecea6760e
start
746
context exact
(PSA) level For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ( 1 )
kind
biomarker
polarity
not_inferred
span
end
987
end exclusive
true
exact text
PSMA-directed therapy as described in the pr
label id
56f3be9c-a86f-4ce5-9e52-e9e57fb95464
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
e0d1d01071505b14ba25492ff0b547560ea8262113f9e85e10359cdecea6760e
start
943

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 1042
end exclusive: true
exact text: 1 INDICATIONS AND USAGE ILLUCCIX, after radiolabeling with Ga 68, 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 For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ILLUCCIX, after radiolabeling with Ga 68, 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 For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ( 1 )
label id: 56f3be9c-a86f-4ce5-9e52-e9e57fb95464
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: e0d1d01071505b14ba25492ff0b547560ea8262113f9e85e10359cdecea6760e
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2256f3be9c-a86f-4ce5-9e52-e9e57fb95464%22

spl effective date

2026-06-15

spl set id

d4643b31-9b4f-673f-e053-2a95a90a559d

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

Preserved source evidence · Not medical advice