isavuconazonium Injection
- Brand(s)
- Cresemba
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Fujisawa Healthcare, Inc. (2015-06-30)
- Oldest Current Product
- 2015-03-06
- License(s)
- NDA
- RxNORM
- INJECTION\ISAVUCONAZONIUM
- FDAOB
- IV (INFUSION)\POWDER\ISAVUCONAZONIUM SULFATE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ISAVUCONAZONIUM SULFATE
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ISAVUCONAZOLE
product(s) by strength(s)
isavuconazonium sulfate 372 mg injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 004690420 | Cresemba | NDA | Fujisawa Healthcare, Inc. | 2015-03-06 | ISAVUCONAZONIUM SULFATE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA207501 | 8f7f73b8-586a-4df0-935f-fecd4696c16c |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA207501 | CRESEMBA | ASTELLAS PHARMA US INC | 2015-03-06 | p6812238 p7459561 | NEW CHEMICAL ENTITY [2020-03-06] ORPHAN DRUG EXCLUSIVITY [2022-03-06] Generating Antibiotic Incentives Now [2027-03-06] Generating Antibiotic Incentives Now [2025-03-06] | NDA207501_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|
| 1 | NDA207501_001 | RX | ISAVUCONAZONIUM SULFATE (372MG) | POWDER | True | 2015-03-06 | CRESEMBA |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p6812238 (view patent) | 2020-10-31 | NDA207501, NDA207500 | isavuconazonium Oral Capsule |
| 2 | p7459561 (view patent) | 2020-10-31 | NDA207501, NDA207500 | isavuconazonium Oral Capsule |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 8f7f73b8-586a-4df0-935f-fecd4696c16c (view SPL) | These highlights do not include all the information needed to use CRESEMBA safely and effectively. See full prescribing information for CRESEMBA. CRESEMBA (isavuconazonium sulfate) Capsules for oral administrationFor Injection for intravenous administrationInitial U.S. Approval: 2015 | prescription | Human Prescription | Fujisawa Healthcare, Inc. | 2015-06-30 | 5 | 004690420, 004690520 | isavuconazonium Oral Capsule |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII