LABELS · 1cafe88a-b7a2-42ff-bb99-3dd17538c58b

SOMATULINE DEPOT

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: 2024-10-11
Captured: 2026-09-09T23:37:39.774134+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE SOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ( 1.1 ) the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. ( 1.2 ) the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. ( 1.3 ) 1.1 Acromegaly SOMATULINE DEPOT is indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal. 1.2 Gastroenteropancreatic Neuroendocrine Tumors SOMATULINE DEPOT is indicated for the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. 1.3 Carcinoid Syndrome SOMATULINE DEPOT is indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

Full extracted label fields

application numbers

NDA022074

boxed warning exact

brand names

SOMATULINE DEPOT

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e4a41fd-a753-4362-87ee-8cc56ed3660d

generic names

LANREOTIDE ACETATE

1cafe88a-b7a2-42ff-bb99-3dd17538c58b

indications and usage exact

1 INDICATIONS AND USAGE SOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ( 1.1 ) the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. ( 1.2 ) the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. ( 1.3 ) 1.1 Acromegaly SOMATULINE DEPOT is indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal. 1.2 Gastroenteropancreatic Neuroendocrine Tumors SOMATULINE DEPOT is indicated for the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. 1.3 Carcinoid Syndrome SOMATULINE DEPOT is indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

indications and usage tables exact

is original packager

true

manufacturer names

Ipsen Biopharmaceuticals, Inc.

matched search terms

tumors

package ndcs

15054-1060-4
15054-1090-4
15054-1120-4

product ndcs

15054-1060
15054-1090
15054-1120

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Warnings & Precautions, Steatorrhea and Malabsorption of Dietary Fats ( 5.6 ) 07/2024

record type

complete_spl_indications_section_candidate

routes

SUBCUTANEOUS

rxcuis

749811
749813
749814
749816
749817
749818

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00000.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: 0
total: 830

terms

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

sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cafe88a-b7a2-42ff-bb99-3dd17538c58b%22

spl effective date

2024-10-11

spl effective time

20241011

spl set id

6e4a41fd-a753-4362-87ee-8cc56ed3660d

spl version

substance names

LANREOTIDE ACETATE

uniis

IEU56G3J9C

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
NDA022074
payload
all indexed label documents
Appl No
022074
Application Docs Date
2007-09-04 00:00:00
Application Docs ID
16896
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022074lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
022074
Application Docs Date
2011-03-07 00:00:00
Application Docs ID
16897
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022074s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
022074
Application Docs Date
2014-10-29 00:00:00
Application Docs ID
16898
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s004lbledt.pdf
Submission No
4
Submission Type
SUPPL
Appl No
022074
Application Docs Date
2013-12-03 00:00:00
Application Docs ID
16899
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022074s006lbl.pdf
Submission No
6
Submission Type
SUPPL
Appl No
022074
Application Docs Date
2015-01-09 00:00:00
Application Docs ID
16900
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s010lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
022074
Application Docs Date
2014-12-16 00:00:00
Application Docs ID
16901
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s011lbl.pdf
Submission No
11
Submission Type
SUPPL
Appl No
022074
Application Docs Date
2017-09-19 00:00:00
Application Docs ID
49775
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022074s017lbl.pdf
Submission No
17
Submission Type
SUPPL
Appl No
022074
Application Docs Date
2018-02-23 00:00:00
Application Docs ID
52695
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022074s018lbl.pdf
Submission No
18
Submission Type
SUPPL
Appl No
022074
Application Docs Date
2019-01-09 00:00:00
Application Docs ID
57151
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022074s022lbl.pdf
Submission No
22
Submission Type
SUPPL
Appl No
022074
Application Docs Date
2019-04-12 00:00:00
Application Docs ID
58307
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022074s024lbl.pdf
Submission No
24
Submission Type
SUPPL
Appl No
022074
Application Docs Date
2023-01-11 00:00:00
Application Docs ID
73142
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022074Orig1s021lbl.pdf
Submission No
21
Submission Type
SUPPL
Appl No
022074
Application Docs Date
2023-02-27 00:00:00
Application Docs ID
73608
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022074s026lbl.pdf
Submission No
26
Submission Type
SUPPL
all submission records
Appl No
022074
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
32
Submission Status
AP
Submission Status Date
2024-07-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022074
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
26
Submission Status
AP
Submission Status Date
2023-02-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022074
Review Priority
901 REQUIRED
Submission Class Code ID
3
Submission No
24
Submission Status
AP
Submission Status Date
2019-04-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022074
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
22
Submission Status
AP
Submission Status Date
2018-12-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022074
Review Priority
N/A
Submission Class Code ID
4
Submission No
21
Submission Status
AP
Submission Status Date
2019-06-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022074
Review Priority
N/A
Submission Class Code ID
4
Submission No
20
Submission Status
AP
Submission Status Date
2017-10-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022074
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
18
Submission Status
AP
Submission Status Date
2018-02-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022074
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
17
Submission Status
AP
Submission Status Date
2017-09-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022074
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
15
Submission Status
AP
Submission Status Date
2015-12-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022074
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
14
Submission Status
AP
Submission Status Date
2015-11-02 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022074
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
13
Submission Status
AP
Submission Status Date
2015-06-01 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022074
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
12
Submission Status
AP
Submission Status Date
2015-06-01 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA022074
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=022074
has approved submission record
true
latest approved submission date
2024-07-11
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
022074
Application Docs Date
2024-07-15 00:00:00
Application Docs ID
79087
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022074s032lbl.pdf
Submission No
32
Submission Type
SUPPL
official application record
Appl No
022074
Appl Public Notes
Appl Type
NDA
Sponsor Name
IPSEN PHARMA
openfda application present
true
products
Active Ingredient
LANREOTIDE ACETATE
Appl No
022074
Drug Name
SOMATULINE DEPOT
Form
SOLUTION;SUBCUTANEOUS
Product No
001
Reference Drug
1
Reference Standard
1
Strength
EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
marketing status
Prescription
Active Ingredient
LANREOTIDE ACETATE
Appl No
022074
Drug Name
SOMATULINE DEPOT
Form
SOLUTION;SUBCUTANEOUS
Product No
002
Reference Drug
1
Reference Standard
1
Strength
EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
marketing status
Prescription
Active Ingredient
LANREOTIDE ACETATE
Appl No
022074
Drug Name
SOMATULINE DEPOT
Form
SOLUTION;SUBCUTANEOUS
Product No
003
Reference Drug
1
Reference Standard
1
Strength
EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
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

NDA022074

brand names

SOMATULINE DEPOT

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 422
end exclusive: true
exact text: 1 INDICATIONS AND USAGE SOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ( 1.1 ) the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progre
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start: 0

current approval status

not_reconciled

duplicate text group

dup-106aec27189d76c2262d

extraction review status

automated_candidate_pending_source_review

generic names

LANREOTIDE ACETATE

ind-span-a39f8abf00f7d751563c

label id

1cafe88a-b7a2-42ff-bb99-3dd17538c58b

positive predicate support span

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exact text: is a somatostatin analog indicated
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start: 41

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

source span

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end exclusive: true
exact text: 1 INDICATIONS AND USAGE SOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
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source text sha256: 7ff6ac2f5464e9765260f1f54d36fa9ac569ff1573b71fafb6548631ceca01db
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cafe88a-b7a2-42ff-bb99-3dd17538c58b%22

spl effective date

2024-10-11

spl set id

6e4a41fd-a753-4362-87ee-8cc56ed3660d

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

non_oncology_or_unclear_candidate

Passage 2 · positive indication candidate

application numbers

NDA022074

brand names

SOMATULINE DEPOT

classification reasons

inherited_predicate_from_same_label_section_requires_review
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 642
end exclusive: true
exact text: SOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ( 1.1 ) the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. ( 1.2 ) the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. ( 1.3 ) 1.1 Acromegaly SOMATULINE DEPOT is indicated f
label id: 1cafe88a-b7a2-42ff-bb99-3dd17538c58b
offset unit: unicode_code_points
source array index: 0
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source text sha256: 7ff6ac2f5464e9765260f1f54d36fa9ac569ff1573b71fafb6548631ceca01db
start: 23

current approval status

not_reconciled

duplicate text group

dup-8afccc60b4ac458bea9f

extraction review status

automated_candidate_pending_source_review

generic names

LANREOTIDE ACETATE

ind-span-68e19048fd8ef98b2127

label id

1cafe88a-b7a2-42ff-bb99-3dd17538c58b

positive predicate support span

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exact text: is a somatostatin analog indicated
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source text sha256: 7ff6ac2f5464e9765260f1f54d36fa9ac569ff1573b71fafb6548631ceca01db
start: 41

qualifier mentions

context exact
( 1.1 ) the treatment of adult patients with unresectable, well- or moderately-differentiated, loca
kind
age
polarity
not_inferred
span
end
262
end exclusive
true
exact text
adult patients
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source text sha256
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start
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context exact
le, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival
kind
biomarker
polarity
not_inferred
span
end
381
end exclusive
true
exact text
metastatic gastroenteropancreatic neuroendo
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1cafe88a-b7a2-42ff-bb99-3dd17538c58b
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source text sha256
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start
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context exact
( 1.1 ) the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or me
kind
stage_or_setting
polarity
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exact text
unresectable
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start
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context exact
ents with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-f
kind
stage_or_setting
polarity
not_inferred
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exact text
locally advanced or metastatic gastroenteropancreat
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source text sha256
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start
318

regulatory links

schema version

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source batch sha256

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source defined aliases

source span

end: 442
end exclusive: true
exact text: ( 1.1 ) the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
label id: 1cafe88a-b7a2-42ff-bb99-3dd17538c58b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 7ff6ac2f5464e9765260f1f54d36fa9ac569ff1573b71fafb6548631ceca01db
start: 223

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cafe88a-b7a2-42ff-bb99-3dd17538c58b%22

spl effective date

2024-10-11

spl set id

6e4a41fd-a753-4362-87ee-8cc56ed3660d

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 · positive indication candidate

application numbers

NDA022074

brand names

SOMATULINE DEPOT

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 787
end exclusive: true
exact text: t of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. ( 1.2 ) the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. ( 1.3 ) 1.1 Acromegaly SOMATULINE DEPOT is indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or
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current approval status

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generic names

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label id

1cafe88a-b7a2-42ff-bb99-3dd17538c58b

positive predicate support span

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exact text: is a somatostatin analog indicated
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Preserved source evidence · Not medical advice