LABELS · fd205110-15eb-4707-82b2-185e5bbf616b

Lanreotide Acetate

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: 2024-09-01
Captured: 2026-09-09T23:38:04.335995+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Lanreotide Injection 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 Lanreotide Injection 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 Lanreotide Injection 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 Lanreotide Injection 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

NDA215395

boxed warning exact

brand names

Lanreotide Acetate

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=11da176a-99bc-4ada-8b3f-6bd2b37a6313

generic names

LANREOTIDE ACETATE

fd205110-15eb-4707-82b2-185e5bbf616b

indications and usage exact

1 INDICATIONS AND USAGE Lanreotide Injection 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 Lanreotide Injection 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 Lanreotide Injection 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 Lanreotide Injection 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

Cipla USA Inc.

matched search terms

tumors

package ndcs

69097-880-67
69097-890-67
69097-870-67

product ndcs

69097-870
69097-880
69097-890

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage, Carcinoid Syndrome ( 1.3 ) 09/2024 Dosage and Administration ( 2.1 ) 09/2024 Warnings and Precautions, Steatorrhea and Malabsorption of Dietary Fats ( 5.6 ) 07/2024

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source batch

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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

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brand names

Lanreotide Acetate

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exact text: 1 INDICATIONS AND USAGE Lanreotide Injection 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 progr
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exact text: reotide Injection 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 Lanreotide Injection is indicat
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Passage 3 · positive indication candidate

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exact text: 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 Lanreotide Injection 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 an
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Passage 4 · unclassified context

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exact text: umors (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 Lanreotide Injection 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 rad
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exact text: EP-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 Lanreotide Injection 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 Lanreotide Injection is ind
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Lanreotide Acetate

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

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exact text: d/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 Lanreotide Injection 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 Lanreotide Injection is indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.
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current approval status

not_reconciled

duplicate text group

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extraction review status

automated_candidate_pending_source_review

generic names

LANREOTIDE ACETATE

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label id

fd205110-15eb-4707-82b2-185e5bbf616b

positive predicate support span

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exact text: is indicated
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qualifier mentions

context exact
mors Lanreotide Injection is indicated for the treatment of adult patients with unresectable, well or moderately differentiated, local
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exact text
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context exact
ble, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival
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1187
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exact text
metastatic gastroenteropancreatic neuroendo
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context exact
ction is indicated for the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or met
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exact text
unresectable
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context exact
ients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-f
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exact text
locally advanced or metastatic gastroenteropancreat
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regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

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exact text: 1.2 Gastroenteropancreatic Neuroendocrine Tumors Lanreotide Injection 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.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22fd205110-15eb-4707-82b2-185e5bbf616b%22

spl effective date

2024-09-01

spl set id

11da176a-99bc-4ada-8b3f-6bd2b37a6313

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 8 · positive indication candidate

application numbers

NDA215395

brand names

Lanreotide Acetate

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: 1446
end exclusive: true
exact text: nt 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 Lanreotide Injection is indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.
label id: fd205110-15eb-4707-82b2-185e5bbf616b
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source text sha256: 00d7f5e85c0016a2697054188f9a8f6acdb8aa3bf1c10d99500ec29a527f80ec
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current approval status

not_reconciled

duplicate text group

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extraction review status

automated_candidate_pending_source_review

generic names

LANREOTIDE ACETATE

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label id

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positive predicate support span

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exact text: is indicated
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source text sha256: 00d7f5e85c0016a2697054188f9a8f6acdb8aa3bf1c10d99500ec29a527f80ec
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qualifier mentions

context exact
rome Lanreotide Injection is indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequenc
kind
age
polarity
not_inferred
span
end
1333
end exclusive
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exact text
adults
label id
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source text sha256
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start
1327

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 1446
end exclusive: true
exact text: 1.3 Carcinoid Syndrome Lanreotide Injection is indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.
label id: fd205110-15eb-4707-82b2-185e5bbf616b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 00d7f5e85c0016a2697054188f9a8f6acdb8aa3bf1c10d99500ec29a527f80ec
start: 1249

source url

https://api.fda.gov/drug/label.json?search=id%3A%22fd205110-15eb-4707-82b2-185e5bbf616b%22

spl effective date

2024-09-01

spl set id

11da176a-99bc-4ada-8b3f-6bd2b37a6313

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

Preserved source evidence · Not medical advice