palonosetron Injectable Solution

Brand(s)
Aloxi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eisai Inc. (2014-09-30)
Oldest Current Product
2014-05-28
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\PALONOSETRON
FDAOB
INTRAVENOUS\INJECTION\PALONOSETRON HYDROCHLORIDE
SPL Active
INTRAVENOUS\INJECTION\PALONOSETRON HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION\PALONOSETRON

product(s) by strength(s)

palonosetron 0.05 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560797AloxiNDAEisai Inc.2014-05-28PALONOSETRON HYDROCHLORIDEINTRAVENOUSINJECTIONNDA0213721b51c34d-9631-4520-83af-6f6fb21a58a4

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA090713PALONOSETRON HYDROCHLORIDETEVA PHARMACEUTICALS USA2015-10-13ANDA090713_001, ANDA090713_002
2ANDA202521PALONOSETRON HYDROCHLORIDESANDOZ INC2015-10-13ANDA202521_001
3NDA021372ALOXIHELSINN HEALTHCARE SA2003-07-25p8729094, PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING, SUBSTANCE
p5202333, PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING/ PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING, SUBSTANCE
p9173942, SUBSTANCE
p9066980, PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING, SUBSTANCE
p9125905, SUBSTANCE
p7960424, SUBSTANCE
p8518981, SUBSTANCE
p8598219, SUBSTANCE
p8598218, SUBSTANCE
p7947724, SUBSTANCE
p7947725, SUBSTANCE
PREVENTION OF ACUTE NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF EMETOGENIC CANCER CHEMOTHERAPY [2017-05-27]
PEDIATRIC EXCLUSIVITY [2017-11-27]
ADDITIONAL INFORMATION ADDED TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE LABELING REGARDING POST-OPERATIVE NAUSEA AND VOMITING STUDIES IN PEDIATRIC PATIENTS [2017-05-27]
NDA021372_001, NDA021372_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA090713_001RXPALONOSETRON HYDROCHLORIDE (EQ 0.25MG BASE/5ML)INTRAVENOUSINJECTIONFalseAP2015-10-13PALONOSETRON HYDROCHLORIDE
2ANDA090713_002RXPALONOSETRON HYDROCHLORIDE (EQ 0.075MG BASE/1.5ML)INTRAVENOUSINJECTIONFalseAP2015-10-13PALONOSETRON HYDROCHLORIDE
3ANDA202521_001RXPALONOSETRON HYDROCHLORIDE (EQ 0.25MG BASE/5ML)INTRAVENOUSINJECTIONFalseAP2015-10-13PALONOSETRON HYDROCHLORIDE
4NDA021372_001RXPALONOSETRON HYDROCHLORIDE (EQ 0.25MG BASE/5ML)INTRAVENOUSINJECTIONTrueAP2003-07-25ALOXI
5NDA021372_002RXPALONOSETRON HYDROCHLORIDE (EQ 0.075MG BASE/1.5ML)INTRAVENOUSINJECTIONTrueAP2008-02-29ALOXI

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5202333 (view patent)2015-04-13NDA021372, NDA022233, NDA205718netupitant / palonosetron Oral Capsule
palonosetron Oral Capsule
2p7947724 (view patent)2024-01-30NDA021372
3p7947725 (view patent)2024-01-30NDA021372
4p7960424 (view patent)2024-01-30NDA021372
5p8518981 (view patent)2024-01-30NDA021372
6p8598218 (view patent)2024-01-30NDA021372
7p8598219 (view patent)2024-01-30NDA021372
8p8729094 (view patent)2024-01-30NDA021372
9p9066980 (view patent)2024-01-30NDA021372
10p9125905 (view patent)2024-01-30NDA021372
11p9173942 (view patent)2024-01-30NDA021372

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11b51c34d-9631-4520-83af-6f6fb21a58a4 (view SPL)These highlights do not include all the information needed to use ALOXI safely and effectively. See full prescribing information for ALOXI. ALOXI (palonosetron HCl) Injection for Intravenous Use Initial U.S. Approval: 2003prescriptionHuman PrescriptionEisai Inc.API MANUFACTURE, MANUFACTURE, PACK2014-09-3014628560797, 628560798

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII