LABELS · 40222ff4-0ffc-318f-e063-6294a90aadc2

FOTIVDA

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: 2025-10-01
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. ( 1 )

Full extracted label fields

application numbers

NDA212904

boxed warning exact

brand names

FOTIVDA

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de77155c-ecf2-4f15-9758-21d271449d83

generic names

TIVOZANIB

40222ff4-0ffc-318f-e063-6294a90aadc2

indications and usage exact

1 INDICATIONS AND USAGE FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

AVEO Pharmaceuticals, Inc.

matched search terms

carcinoma

package ndcs

45629-089-01
45629-089-02
45629-134-01
45629-134-02

product ndcs

45629-089
45629-134

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Warnings and Precautions ( 5.7 ) 8/2024

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2534238
2534244
2534247
2534249

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00200.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: 200
total: 830

terms

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

sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%2240222ff4-0ffc-318f-e063-6294a90aadc2%22

spl effective date

2025-10-01

spl effective time

20251001

spl set id

de77155c-ecf2-4f15-9758-21d271449d83

spl version

substance names

TIVOZANIB HYDROCHLORIDE

uniis

8A9H4VK35Z

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
NDA212904
payload
all indexed label documents
Appl No
212904
Application Docs Date
2021-03-29 00:00:00
Application Docs ID
66912
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212904s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
212904
Application Docs Date
2024-08-08 00:00:00
Application Docs ID
79336
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212904s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
212904
Application Docs Date
2025-02-05 00:00:00
Application Docs ID
80969
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212904s003lbl.pdf
Submission No
3
Submission Type
SUPPL
all submission records
Appl No
212904
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2025-01-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
212904
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
2
Submission Status
AP
Submission Status Date
2024-08-06 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
212904
Review Priority
STANDARD
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2021-03-10 00:00:00
Submission Type
ORIG
Submissions Public Notes
application number
NDA212904
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=212904
has approved submission record
true
latest approved submission date
2025-01-30
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
212904
Application Docs Date
2025-02-05 00:00:00
Application Docs ID
80969
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212904s003lbl.pdf
Submission No
3
Submission Type
SUPPL
official application record
Appl No
212904
Appl Public Notes
Appl Type
NDA
Sponsor Name
AVEO PHARMS
openfda application present
true
products
Active Ingredient
TIVOZANIB HYDROCHLORIDE
Appl No
212904
Drug Name
FOTIVDA
Form
CAPSULE;ORAL
Product No
001
Reference Drug
1
Reference Standard
0
Strength
EQ 0.89MG BASE
marketing status
Prescription
Active Ingredient
TIVOZANIB HYDROCHLORIDE
Appl No
212904
Drug Name
FOTIVDA
Form
CAPSULE;ORAL
Product No
002
Reference Drug
1
Reference Standard
1
Strength
EQ 1.34MG BASE
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

NDA212904

brand names

FOTIVDA

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: 386
end exclusive: true
exact text: 1 INDICATIONS AND USAGE FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. ( 1 )
label id: 40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start: 0

current approval status

not_reconciled

duplicate text group

dup-3f5ac4db065e0626d54c

extraction review status

automated_candidate_pending_source_review

generic names

TIVOZANIB

ind-span-55676a234720178240b3

label id

40222ff4-0ffc-318f-e063-6294a90aadc2

positive predicate support span

end: 44
end exclusive: true
exact text: is indicated
label id: 40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start: 32

qualifier mentions

context exact
CATIONS AND USAGE FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (
kind
age
polarity
not_inferred
span
end
80
end exclusive
true
exact text
adult patients
label id
40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start
66
context exact
TIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapi
kind
stage_or_setting
polarity
not_inferred
span
end
129
end exclusive
true
exact text
relapsed or refractory advanced renal cell
label id
40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start
86
context exact
y advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
191
end exclusive
true
exact text
prior systemic therapies
label id
40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start
167

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 192
end exclusive: true
exact text: 1 INDICATIONS AND USAGE FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
label id: 40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2240222ff4-0ffc-318f-e063-6294a90aadc2%22

spl effective date

2025-10-01

spl set id

de77155c-ecf2-4f15-9758-21d271449d83

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 · positive indication candidate

application numbers

NDA212904

brand names

FOTIVDA

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: 386
end exclusive: true
exact text: 1 INDICATIONS AND USAGE FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. ( 1 )
label id: 40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start: 0

current approval status

not_reconciled

duplicate text group

dup-ce250623a37899e5a61d

extraction review status

automated_candidate_pending_source_review

generic names

TIVOZANIB

ind-span-51b713c3041d8c8c3efb

label id

40222ff4-0ffc-318f-e063-6294a90aadc2

positive predicate support span

end: 232
end exclusive: true
exact text: is a kinase inhibitor indicated
label id: 40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start: 201

qualifier mentions

context exact
OTIVDA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (
kind
age
polarity
not_inferred
span
end
268
end exclusive
true
exact text
adult patients
label id
40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start
254
context exact
nhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapi
kind
stage_or_setting
polarity
not_inferred
span
end
317
end exclusive
true
exact text
relapsed or refractory advanced renal cell
label id
40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start
274
context exact
y advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
379
end exclusive
true
exact text
prior systemic therapies
label id
40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start
355

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 380
end exclusive: true
exact text: FOTIVDA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
label id: 40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start: 193

source url

https://api.fda.gov/drug/label.json?search=id%3A%2240222ff4-0ffc-318f-e063-6294a90aadc2%22

spl effective date

2025-10-01

spl set id

de77155c-ecf2-4f15-9758-21d271449d83

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 · unclassified context

application numbers

NDA212904

brand names

FOTIVDA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 386
end exclusive: true
exact text: therapies. FOTIVDA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. ( 1 )
label id: 40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start: 181

current approval status

not_reconciled

duplicate text group

dup-bf42c58db75e12a30a6f

extraction review status

automated_candidate_pending_source_review

generic names

TIVOZANIB

ind-span-908f56232c124749fa8c

label id

40222ff4-0ffc-318f-e063-6294a90aadc2

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 386
end exclusive: true
exact text: ( 1 )
label id: 40222ff4-0ffc-318f-e063-6294a90aadc2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 5273654d2e3cef4a3d3e73cd53041ef3a7298870fd9d252445b7853c1ca38e56
start: 381

source url

https://api.fda.gov/drug/label.json?search=id%3A%2240222ff4-0ffc-318f-e063-6294a90aadc2%22

spl effective date

2025-10-01

spl set id

de77155c-ecf2-4f15-9758-21d271449d83

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