pasireotide Injection

Brand(s)
Signifor
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-03-17)
Oldest Current Product
2012-12-14
License(s)
NDA
RxNORM
INJECTION\PASIREOTIDE
FDAOB
INTRAMUSCULAR\POWDER\PASIREOTIDE PAMOATE
SUBCUTANEOUS\SOLUTION\PASIREOTIDE DIASPARTATE
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SUSPENSION\PASIREOTIDE
SUBCUTANEOUS\INJECTION\PASIREOTIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SUSPENSION\PASIREOTIDE
SUBCUTANEOUS\INJECTION\PASIREOTIDE

product(s) by strength(s)

1 ml pasireotide 0.3 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780633SigniforNDANovartis Pharmaceuticals Corporation2012-12-14PASIREOTIDESUBCUTANEOUSINJECTIONNDA200677442f0d9d-5c7d-4b81-b329-d71be8cf2be2

1 ml pasireotide 0.6 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780634SigniforNDANovartis Pharmaceuticals Corporation2012-12-14PASIREOTIDESUBCUTANEOUSINJECTIONNDA200677442f0d9d-5c7d-4b81-b329-d71be8cf2be2

1 ml pasireotide 0.9 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780635SigniforNDANovartis Pharmaceuticals Corporation2012-12-14PASIREOTIDESUBCUTANEOUSINJECTIONNDA200677442f0d9d-5c7d-4b81-b329-d71be8cf2be2

pasireotide 20 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780641SigniforNDANovartis Pharmaceuticals Corporation2014-12-15PASIREOTIDEINTRAMUSCULARINJECTION, POWDER, FOR SUSPENSIONNDA2032555504116c-d531-4d47-b160-41c6671d52aa

pasireotide 40 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780642SigniforNDANovartis Pharmaceuticals Corporation2014-12-15PASIREOTIDEINTRAMUSCULARINJECTION, POWDER, FOR SUSPENSIONNDA2032555504116c-d531-4d47-b160-41c6671d52aa

pasireotide 60 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780643SigniforNDANovartis Pharmaceuticals Corporation2014-12-15PASIREOTIDEINTRAMUSCULARINJECTION, POWDER, FOR SUSPENSIONNDA2032555504116c-d531-4d47-b160-41c6671d52aa

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA200677SIGNIFORNOVARTIS PHARMACEUTICALS CORP2012-12-14p7473761, SUBSTANCE
p6225284, SUBSTANCE
p8299209, SUBSTANCE
NEW CHEMICAL ENTITY [2017-12-14]
ORPHAN DRUG EXCLUSIVITY [2019-12-14]
NDA200677_001, NDA200677_002, NDA200677_003
2NDA203255SIGNIFOR LARNOVARTIS PHARMACEUTICALS CORP2014-12-15p8822637, METHOD OF TREATING ACROMEGALY
p7473761, SUBSTANCE
p6225284, METHOD OF TREATING DISORDERS WITH AN ETIOLOGY COMPRISING OR ASSOCIATED WITH EXCESS GH-SECRETION, SUBSTANCE
p7759308, SUBSTANCE
NEW CHEMICAL ENTITY [2017-12-14]
NEW PRODUCT [2017-12-15]
ORPHAN DRUG EXCLUSIVITY [2021-12-15]
NDA203255_001, NDA203255_002, NDA203255_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA200677_001RXPASIREOTIDE DIASPARTATE (EQ 0.3MG BASE/ML)SUBCUTANEOUSSOLUTIONFalse2012-12-14SIGNIFOR
2NDA200677_002RXPASIREOTIDE DIASPARTATE (EQ 0.6MG BASE/ML)SUBCUTANEOUSSOLUTIONFalse2012-12-14SIGNIFOR
3NDA200677_003RXPASIREOTIDE DIASPARTATE (EQ 0.9MG BASE/ML)SUBCUTANEOUSSOLUTIONTrue2012-12-14SIGNIFOR
4NDA203255_001RXPASIREOTIDE PAMOATE (EQ 20MG BASE/VIAL)INTRAMUSCULARPOWDERFalse2014-12-15SIGNIFOR LAR
5NDA203255_002RXPASIREOTIDE PAMOATE (EQ 40MG BASE/VIAL)INTRAMUSCULARPOWDERFalse2014-12-15SIGNIFOR LAR
6NDA203255_003RXPASIREOTIDE PAMOATE (EQ 60MG BASE/VIAL)INTRAMUSCULARPOWDERTrue2014-12-15SIGNIFOR LAR

patent(s)

#idexpiration dateapplication(s)
1p6225284 (view patent)2016-06-28NDA200677, NDA203255
2p7473761 (view patent)2025-07-29NDA200677, NDA203255
3p7759308 (view patent)2026-10-25NDA203255
4p8299209 (view patent)2025-12-27NDA200677
5p8822637 (view patent)2023-08-06NDA203255

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1442f0d9d-5c7d-4b81-b329-d71be8cf2be2 (view SPL)These highlights do not include all the information needed to use SIGNIFOR safely and effectively. See full prescribing information for SIGNIFOR. SIGNIFOR (pasireotide) injection, for subcutaneous use Initial U.S. Approval: 2012prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-03-172000780633, 000780634, 000780635
25504116c-d531-4d47-b160-41c6671d52aa (view SPL)These highlights do not include all the information needed to use SIGNIFOR LAR safely and effectively. See full prescribing information for SIGNIFOR LAR. SIGNIFOR LAR (pasireotide) for injectable suspension, for intramuscular use Initial U.S. Approval: 2012prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2014-12-152000780641, 000780642, 000780643

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