Overview
Valrubicin (N-trifluoroacetyladriamycin-14-valerate) is a chemotherapy drug commonly marketed under the trade name VALSTAR. It is a semisynthetic analog of the doxorubicin, which is an anthracycline drug. Used in the treatment of the bladder cancer, valrubicin is administered by direct infusion into the bladder.
Indication
For the treatment of cancer of the bladder.
Associated Conditions
- In situ BCG-refractory Bladder carcinoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2012/05/25 | Phase 1 | Completed | |||
2011/03/09 | Phase 3 | Terminated | Endo Pharmaceuticals | ||
2004/07/22 | Phase 3 | UNKNOWN | Anthra Pharmaceuticals | ||
2003/07/18 | Phase 2 | Completed | Anthra Pharmaceuticals | ||
2003/04/18 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Endo Pharmaceuticals Solutions Inc. | 67979-001 | INTRAVESICAL | 40 mg in 1 mL | 10/25/2023 | |
| Hikma Pharmaceuticals USA Inc. | 24201-101 | INTRAVESICAL | 40 mg in 1 mL | 6/30/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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