LABELS · 04460041-adec-463b-ba9d-6a12038ab672

palonosetron hydrochloride

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: 2022-01-13
Captured: 2026-09-09T23:37:39.774134+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in adults for: Moderately emetogenic cancer chemotherapy - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses ( 1 .1) Highly emetogenic cancer chemotherapy - prevention of acute nausea and vomiting associated with initial and repeat courses ( 1.1 ) Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated ( 1.3 ) Palonosetron Hydrochloride Injection is indicated in pediatric patients aged 1 month to less than 17 years for: Prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy ( 1.2 ) 1.1 Chemotherapy-Induced Nausea and Vomiting in Adults Palonosetron Hydrochloride Injection is indicated for: Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses 1.2 Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients Aged 1 Month to Less than 17 Years Palonosetron Hydrochloride Injection is indicated for prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. 1.3 Postoperative Nausea and Vomiting in Adults Palonosetron Hydrochloride Injection is indicated for prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, Palonosetron Hydrochloride Injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.

Full extracted label fields

application numbers

NDA021372

boxed warning exact

brand names

palonosetron hydrochloride

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=37e7ef89-fd77-44e0-9271-ae91f8822603

generic names

PALONOSETRON HYDROCHLORIDE

04460041-adec-463b-ba9d-6a12038ab672

indications and usage exact

1 INDICATIONS AND USAGE Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in adults for: Moderately emetogenic cancer chemotherapy - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses ( 1 .1) Highly emetogenic cancer chemotherapy - prevention of acute nausea and vomiting associated with initial and repeat courses ( 1.1 ) Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated ( 1.3 ) Palonosetron Hydrochloride Injection is indicated in pediatric patients aged 1 month to less than 17 years for: Prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy ( 1.2 ) 1.1 Chemotherapy-Induced Nausea and Vomiting in Adults Palonosetron Hydrochloride Injection is indicated for: Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses 1.2 Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients Aged 1 Month to Less than 17 Years Palonosetron Hydrochloride Injection is indicated for prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. 1.3 Postoperative Nausea and Vomiting in Adults Palonosetron Hydrochloride Injection is indicated for prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, Palonosetron Hydrochloride Injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.

indications and usage tables exact

is original packager

true

manufacturer names

Cipla USA Inc.

matched search terms

cancer

package ndcs

69097-927-35

product ndcs

69097-927

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

RECENT MAJOR CHANGES Indication ( 1.2 ) 05/2014 Dosage and Administration, Pediatric Cancer Patients ( 2.1 ) 05/2014 Warnings and Precautions, Serotonin Syndrome ( 5.2 ) 09/2014

record type

complete_spl_indications_section_candidate

routes

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rxcuis

1728055

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

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url

source url

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spl effective date

2022-01-13

spl effective time

20220113

spl set id

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spl version

substance names

PALONOSETRON HYDROCHLORIDE

uniis

23310D4I19

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
NDA021372
payload
all indexed label documents
Appl No
021372
Application Docs Date
2005-07-07 00:00:00
Application Docs ID
15334
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021372s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
021372
Application Docs Date
2007-09-04 00:00:00
Application Docs ID
15335
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021372s006lbl.pdf
Submission No
6
Submission Type
SUPPL
Appl No
021372
Application Docs Date
2008-03-05 00:00:00
Application Docs ID
15336
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021372s008s010lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
021372
Application Docs Date
2014-05-28 00:00:00
Application Docs ID
15337
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s018s019lbl.pdf
Submission No
19
Submission Type
SUPPL
Appl No
021372
Application Docs Date
2014-09-22 00:00:00
Application Docs ID
15338
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s020lbl.pdf
Submission No
20
Submission Type
SUPPL
Appl No
021372
Application Docs Date
2003-08-06 00:00:00
Application Docs ID
36791
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21372_aloxi_lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
021372
Application Docs Date
2006-08-29 00:00:00
Application Docs ID
36792
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021372s005lbl.pdf
Submission No
5
Submission Type
SUPPL
Appl No
021372
Application Docs Date
2008-03-05 00:00:00
Application Docs ID
36793
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021372s008s010lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
021372
Application Docs Date
2014-02-07 00:00:00
Application Docs ID
36794
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s017lbl.pdf
Submission No
17
Submission Type
SUPPL
Appl No
021372
Application Docs Date
2020-04-02 00:00:00
Application Docs ID
62422
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021372s021lbl.pdf
Submission No
21
Submission Type
SUPPL
all submission records
Appl No
021372
Review Priority
STANDARD
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2003-07-25 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
021372
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
2
Submission Status
AP
Submission Status Date
2005-07-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021372
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
5
Submission Status
AP
Submission Status Date
2006-08-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021372
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
6
Submission Status
AP
Submission Status Date
2007-08-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021372
Review Priority
UNKNOWN
Submission Class Code ID
2
Submission No
8
Submission Status
AP
Submission Status Date
2008-02-29 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021372
Review Priority
UNKNOWN
Submission Class Code ID
2
Submission No
10
Submission Status
AP
Submission Status Date
2008-02-29 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021372
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
17
Submission Status
AP
Submission Status Date
2014-02-06 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021372
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
18
Submission Status
AP
Submission Status Date
2014-05-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021372
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
19
Submission Status
AP
Submission Status Date
2014-05-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021372
Review Priority
901 REQUIRED
Submission Class Code ID
3
Submission No
20
Submission Status
AP
Submission Status Date
2014-09-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021372
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
21
Submission Status
AP
Submission Status Date
2020-04-01 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA021372
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
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has approved submission record
true
latest approved submission date
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latest posted label documents
Appl No
021372
Application Docs Date
2020-04-02 00:00:00
Application Docs ID
62422
Application Docs Title
0
Application Docs Type ID
2
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021372s021lbl.pdf
Submission No
21
Submission Type
SUPPL
official application record
Appl No
021372
Appl Public Notes
Appl Type
NDA
Sponsor Name
HELSINN HLTHCARE
openfda application present
true
products
Active Ingredient
PALONOSETRON HYDROCHLORIDE
Appl No
021372
Drug Name
ALOXI
Form
INJECTABLE;INTRAVENOUS
Product No
001
Reference Drug
1
Reference Standard
0
Strength
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
marketing status
Discontinued
Active Ingredient
PALONOSETRON HYDROCHLORIDE
Appl No
021372
Drug Name
ALOXI
Form
INJECTABLE;INTRAVENOUS
Product No
002
Reference Drug
1
Reference Standard
0
Strength
EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
marketing status
Discontinued

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

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