LABELS · 2c75a415-0b1e-4c36-8301-c50ac155d980

Halaven

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: 2025-11-07
Captured: 2026-09-09T23:37:42.544548+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE HALAVEN is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. ( 1.1 ) Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. ( 1.2 ) 1.1 Me tastatic Breast Cancer HALAVEN is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting [see Clinical Studies (14.1) ] . 1.2 Liposarcoma HALAVEN is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen [see Clinical Studies (14.2) ] .

Full extracted label fields

application numbers

NDA201532

boxed warning exact

brand names

Halaven

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=31ce4750-ded5-4a0b-95e9-f229fa6bc822

generic names

ERIBULIN MESYLATE

2c75a415-0b1e-4c36-8301-c50ac155d980

indications and usage exact

1 INDICATIONS AND USAGE HALAVEN is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. ( 1.1 ) Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. ( 1.2 ) 1.1 Me tastatic Breast Cancer HALAVEN is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting [see Clinical Studies (14.1) ] . 1.2 Liposarcoma HALAVEN is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen [see Clinical Studies (14.2) ] .

indications and usage tables exact

is original packager

true

manufacturer names

Eisai Inc.

matched search terms

cancer

package ndcs

62856-389-01

product ndcs

62856-389

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Instructions for Preparation and Administration ( 2.3 ) 09/2021

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

1045456
1045460

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00100.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: 100
total: 830

terms

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

sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%222c75a415-0b1e-4c36-8301-c50ac155d980%22

spl effective date

2025-11-07

spl effective time

20251107

spl set id

31ce4750-ded5-4a0b-95e9-f229fa6bc822

spl version

substance names

ERIBULIN MESYLATE

uniis

AV9U0660CW

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
NDA201532
payload
all indexed label documents
Appl No
201532
Application Docs Date
2015-11-04 00:00:00
Application Docs ID
19024
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201532s013lbl.pdf
Submission No
13
Submission Type
SUPPL
Appl No
201532
Application Docs Date
2016-01-28 00:00:00
Application Docs ID
19025
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s015lbl.pdf
Submission No
15
Submission Type
SUPPL
Appl No
201532
Application Docs Date
2010-11-15 00:00:00
Application Docs ID
40071
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201532lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
201532
Application Docs Date
2012-02-22 00:00:00
Application Docs ID
40072
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201532s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
201532
Application Docs Date
2013-08-27 00:00:00
Application Docs ID
40073
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201532s006lbl.pdf
Submission No
6
Submission Type
SUPPL
Appl No
201532
Application Docs Date
2014-08-04 00:00:00
Application Docs ID
40074
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s009lbl.pdf
Submission No
9
Submission Type
SUPPL
Appl No
201532
Application Docs Date
2015-01-09 00:00:00
Application Docs ID
40075
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s010lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
201532
Application Docs Date
2016-10-27 00:00:00
Application Docs ID
45685
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s016lbl.pdf
Submission No
16
Submission Type
SUPPL
Appl No
201532
Application Docs Date
2022-01-05 00:00:00
Application Docs ID
69812
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201532Orig1s021lbl.pdf
Submission No
21
Submission Type
SUPPL
Appl No
201532
Application Docs Date
2022-09-14 00:00:00
Application Docs ID
72078
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201532s023lbl.pdf
Submission No
23
Submission Type
SUPPL
all submission records
Appl No
201532
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2010-11-15 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
201532
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2012-02-17 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
201532
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
5
Submission Status
AP
Submission Status Date
2012-11-07 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
201532
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
6
Submission Status
AP
Submission Status Date
2013-08-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
201532
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
7
Submission Status
AP
Submission Status Date
2013-09-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
201532
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
8
Submission Status
AP
Submission Status Date
2013-10-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
201532
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
9
Submission Status
AP
Submission Status Date
2014-08-01 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
201532
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
10
Submission Status
AP
Submission Status Date
2014-12-19 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
201532
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
12
Submission Status
AP
Submission Status Date
2015-04-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
201532
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
13
Submission Status
AP
Submission Status Date
2015-10-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
201532
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
14
Submission Status
AP
Submission Status Date
2015-11-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
201532
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
15
Submission Status
AP
Submission Status Date
2016-01-28 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA201532
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=201532
has approved submission record
true
latest approved submission date
2022-09-13
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
201532
Application Docs Date
2022-09-14 00:00:00
Application Docs ID
72078
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201532s023lbl.pdf
Submission No
23
Submission Type
SUPPL
official application record
Appl No
201532
Appl Public Notes
Appl Type
NDA
Sponsor Name
EISAI INC
openfda application present
true
products
Active Ingredient
ERIBULIN MESYLATE
Appl No
201532
Drug Name
HALAVEN
Form
SOLUTION;INTRAVENOUS
Product No
001
Reference Drug
1
Reference Standard
1
Strength
1MG/2ML (0.5MG/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

NDA201532

brand names

Halaven

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 438
end exclusive: true
exact text: 1 INDICATIONS AND USAGE HALAVEN is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. ( 1.1 ) Unresectable or metastatic liposarcoma who have received a prior anthracycline-c
label id: 2c75a415-0b1e-4c36-8301-c50ac155d980
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9d7a3b4608771e180b96a834e3b8f5660c72e8c5c57d34d71490715b608db11e
start: 0

current approval status

not_reconciled

duplicate text group

dup-f804a58bd56ff153851a

extraction review status

automated_candidate_pending_source_review

generic names

ERIBULIN MESYLATE

ind-span-e2e0e2648db659c1997b

label id

2c75a415-0b1e-4c36-8301-c50ac155d980

positive predicate support span

end: 68
end exclusive: true
exact text: is a microtubule inhibitor indicated
label id: 2c75a415-0b1e-4c36-8301-c50ac155d980
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9d7a3b4608771e180b96a834e3b8f5660c72e8c5c57d34d71490715b608db11e
start: 32

qualifier mentions

context exact
ule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the tr
kind
biomarker
polarity
not_inferred
span
end
148
end exclusive
true
exact text
Metastatic breast cancer who have previousl
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start
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context exact
at least two chemotherapeutic regimens for the treatment of metastatic disease.
kind
biomarker
polarity
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span
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237
end exclusive
true
exact text
metastatic disease
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2c75a415-0b1e-4c36-8301-c50ac155d980
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source field
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source text sha256
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start
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context exact
ule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the trea
kind
stage_or_setting
polarity
not_inferred
span
end
150
end exclusive
true
exact text
Metastatic breast cancer who have previously
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2c75a415-0b1e-4c36-8301-c50ac155d980
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source text sha256
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context exact
at least two chemotherapeutic regimens for the treatment of metastatic disease.
kind
stage_or_setting
polarity
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span
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237
end exclusive
true
exact text
metastatic disease
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2c75a415-0b1e-4c36-8301-c50ac155d980
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source field
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source text sha256
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regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

source span

end: 238
end exclusive: true
exact text: 1 INDICATIONS AND USAGE HALAVEN is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.
label id: 2c75a415-0b1e-4c36-8301-c50ac155d980
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9d7a3b4608771e180b96a834e3b8f5660c72e8c5c57d34d71490715b608db11e
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%222c75a415-0b1e-4c36-8301-c50ac155d980%22

spl effective date

2025-11-07

spl set id

31ce4750-ded5-4a0b-95e9-f229fa6bc822

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 2 · unclassified context

application numbers

NDA201532

brand names

Halaven

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 549
end exclusive: true
exact text: crotubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. ( 1.1 ) Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. ( 1.2 ) 1.1 Me tastatic Breast Cancer HALAVEN is indicated for the treatment of patients wit
label id: 2c75a415-0b1e-4c36-8301-c50ac155d980
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9d7a3b4608771e180b96a834e3b8f5660c72e8c5c57d34d71490715b608db11e
start: 39

current approval status

not_reconciled

duplicate text group

dup-edf0085000e3d8b8f0be

extraction review status

automated_candidate_pending_source_review

generic names

ERIBULIN MESYLATE

ind-span-65e63a66efa61d68642b

label id

2c75a415-0b1e-4c36-8301-c50ac155d980

positive predicate support span

Source null

qualifier mentions

context exact
ded an anthracycline and a taxane in either the adjuvant or metastatic setting.
kind
biomarker
polarity
not_inferred
span
end
348
end exclusive
true
exact text
metastatic setting
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source field
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source text sha256
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context exact
d have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
kind
stage_or_setting
polarity
not_inferred
span
end
348
end exclusive
true
exact text
adjuvant or metastatic setting
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318

regulatory links

schema version

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source batch sha256

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source defined aliases

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end: 349
end exclusive: true
exact text: Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
label id: 2c75a415-0b1e-4c36-8301-c50ac155d980
offset unit: unicode_code_points
source array index: 0
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source text sha256: 9d7a3b4608771e180b96a834e3b8f5660c72e8c5c57d34d71490715b608db11e
start: 239

source url

https://api.fda.gov/drug/label.json?search=id%3A%222c75a415-0b1e-4c36-8301-c50ac155d980%22

spl effective date

2025-11-07

spl set id

31ce4750-ded5-4a0b-95e9-f229fa6bc822

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

Passage 3 · unclassified context

application numbers

NDA201532

brand names

Halaven

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 656
end exclusive: true
exact text: received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. ( 1.1 ) Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. ( 1.2 ) 1.1 Me tastatic Breast Cancer HALAVEN is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the trea
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current approval status

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extraction review status

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generic names

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ind-span-3e76a32502234a442da3

label id

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positive predicate support span

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qualifier mentions

context exact
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kind
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exact text
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context exact
( 1.1 ) Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
kind
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polarity
not_inferred
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end exclusive
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exact text
Unresectable or metastatic liposarcoma who have
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context exact
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kind
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exact text
who have received a prior anthracycline-containing regimen
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start
397

regulatory links

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source defined aliases

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end: 456
end exclusive: true
exact text: ( 1.1 ) Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
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offset unit: unicode_code_points
source array index: 0
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source text sha256: 9d7a3b4608771e180b96a834e3b8f5660c72e8c5c57d34d71490715b608db11e
start: 350

source url

https://api.fda.gov/drug/label.json?search=id%3A%222c75a415-0b1e-4c36-8301-c50ac155d980%22

spl effective date

2025-11-07

spl set id

31ce4750-ded5-4a0b-95e9-f229fa6bc822

spl version

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Preserved source evidence · Not medical advice