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)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 000780633 | Signifor | NDA | Novartis Pharmaceuticals Corporation | 2012-12-14 | PASIREOTIDE | SUBCUTANEOUS | INJECTION | NDA200677 | 442f0d9d-5c7d-4b81-b329-d71be8cf2be2 |
1 ml pasireotide 0.6 mg/ml injection
original product(s)(s)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 000780634 | Signifor | NDA | Novartis Pharmaceuticals Corporation | 2012-12-14 | PASIREOTIDE | SUBCUTANEOUS | INJECTION | NDA200677 | 442f0d9d-5c7d-4b81-b329-d71be8cf2be2 |
1 ml pasireotide 0.9 mg/ml injection
original product(s)(s)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 000780635 | Signifor | NDA | Novartis Pharmaceuticals Corporation | 2012-12-14 | PASIREOTIDE | SUBCUTANEOUS | INJECTION | NDA200677 | 442f0d9d-5c7d-4b81-b329-d71be8cf2be2 |
pasireotide 20 mg injection
original product(s)(s)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 000780641 | Signifor | NDA | Novartis Pharmaceuticals Corporation | 2014-12-15 | PASIREOTIDE | INTRAMUSCULAR | INJECTION, POWDER, FOR SUSPENSION | NDA203255 | 5504116c-d531-4d47-b160-41c6671d52aa |
pasireotide 40 mg injection
original product(s)(s)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 000780642 | Signifor | NDA | Novartis Pharmaceuticals Corporation | 2014-12-15 | PASIREOTIDE | INTRAMUSCULAR | INJECTION, POWDER, FOR SUSPENSION | NDA203255 | 5504116c-d531-4d47-b160-41c6671d52aa |
pasireotide 60 mg injection
original product(s)(s)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 000780643 | Signifor | NDA | Novartis Pharmaceuticals Corporation | 2014-12-15 | PASIREOTIDE | INTRAMUSCULAR | INJECTION, POWDER, FOR SUSPENSION | NDA203255 | 5504116c-d531-4d47-b160-41c6671d52aa |
application(s)
# | id | title | applicant | approved | patent | exclusivity | approved drug |
---|---|---|---|---|---|---|---|
1 | NDA200677 | SIGNIFOR | NOVARTIS PHARMACEUTICALS CORP | 2012-12-14 | p7473761, SUBSTANCE p6225284, SUBSTANCE p8299209, SUBSTANCE | NEW CHEMICAL ENTITY [2017-12-14] ORPHAN DRUG EXCLUSIVITY [2019-12-14] | NDA200677_001, NDA200677_002, NDA200677_003 |
2 | NDA203255 | SIGNIFOR LAR | NOVARTIS PHARMACEUTICALS CORP | 2014-12-15 | p8822637, 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)
# | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
---|---|---|---|---|---|---|---|---|
1 | NDA200677_001 | RX | PASIREOTIDE DIASPARTATE (EQ 0.3MG BASE/ML) | SUBCUTANEOUS | SOLUTION | False | 2012-12-14 | SIGNIFOR |
2 | NDA200677_002 | RX | PASIREOTIDE DIASPARTATE (EQ 0.6MG BASE/ML) | SUBCUTANEOUS | SOLUTION | False | 2012-12-14 | SIGNIFOR |
3 | NDA200677_003 | RX | PASIREOTIDE DIASPARTATE (EQ 0.9MG BASE/ML) | SUBCUTANEOUS | SOLUTION | True | 2012-12-14 | SIGNIFOR |
4 | NDA203255_001 | RX | PASIREOTIDE PAMOATE (EQ 20MG BASE/VIAL) | INTRAMUSCULAR | POWDER | False | 2014-12-15 | SIGNIFOR LAR |
5 | NDA203255_002 | RX | PASIREOTIDE PAMOATE (EQ 40MG BASE/VIAL) | INTRAMUSCULAR | POWDER | False | 2014-12-15 | SIGNIFOR LAR |
6 | NDA203255_003 | RX | PASIREOTIDE PAMOATE (EQ 60MG BASE/VIAL) | INTRAMUSCULAR | POWDER | True | 2014-12-15 | SIGNIFOR LAR |
patent(s)
# | id | expiration date | application(s) |
---|---|---|---|
1 | p6225284 (view patent) | 2016-06-28 | NDA200677, NDA203255 |
2 | p7473761 (view patent) | 2025-07-29 | NDA200677, NDA203255 |
3 | p7759308 (view patent) | 2026-10-25 | NDA203255 |
4 | p8299209 (view patent) | 2025-12-27 | NDA200677 |
5 | p8822637 (view patent) | 2023-08-06 | NDA203255 |
spl(s)
# | id | title | category | type | labeler | last update | version | product(s) |
---|---|---|---|---|---|---|---|---|
1 | 442f0d9d-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: 2012 | prescription | Human Prescription | Novartis Pharmaceuticals Corporation | 2015-03-17 | 2 | 000780633, 000780634, 000780635 |
2 | 5504116c-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: 2012 | prescription | Human Prescription | Novartis Pharmaceuticals Corporation | 2014-12-15 | 2 | 000780641, 000780642, 000780643 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII