Overview
Anidulafungin or Eraxis is an anti-fungal drug manufactured by Pfizer that gained approval by the Food and Drug Administration (FDA) in February 21, 2006; it was previously known as LY303366. There is preliminary evidence that it has a similar safety profile to caspofungin.
Indication
用于治疗食管念珠菌感染，念珠菌性败血症，念珠菌引起的腹腔脓肿及念珠菌性腹膜炎。
Associated Conditions
- Bloodstream Infections (BSI)
- Candidemia
- Candidiasis
- Esophageal Candidiasis
- Fungal peritonitis caused by Candida
- Intraabdominal Abscess caused by Candida
- Invasive Aspergillosis
- Oropharyngeal Candidiasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/06/22 | N/A | Recruiting | Poznan University of Medical Sciences | ||
2021/05/06 | Phase 3 | Terminated | |||
2013/12/27 | Phase 4 | Completed | |||
2012/11/27 | Phase 4 | Completed | |||
2011/03/03 | Phase 4 | Completed | |||
2011/02/24 | Phase 4 | Completed | |||
2010/11/30 | Phase 2 | Completed | |||
2010/09/15 | N/A | Completed | |||
2010/08/25 | Phase 3 | Withdrawn | |||
2010/01/22 | Phase 2 | Terminated | Elisabethinen Hospital |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/20/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ANIDACCORD 100 POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG | SIN16106P | INJECTION, POWDER, FOR SOLUTION | 100 mg | 2/19/2021 | |
| ANIDULAFUNGIN FRESENIUS KABI POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL | SIN16803P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100mg/vial | 6/9/2023 | |
| Eraxis 100mg For Injection | SIN13585P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100mg/vial | 12/17/2008 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ANIDULAFUNGIN JUNO anidulafungin 100 mg powder for injection vial | 353950 | Medicine | A | 3/11/2022 | |
| ERAXIS anidulafungin 100 mg powder for injection vial | 134398 | Medicine | A | 4/3/2009 | |
| Anidulafungin Accord anidulafungin 100 mg powder for injection vial | 390552 | Medicine | A | 2/24/2025 |
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