Overview
Nefazodone hydrochloride (trade name Serzone) is an antidepressant drug marketed by Bristol-Myers Squibb. Its sale was discontinued in 2003 in some countries, due to the small possibility of hepatic (liver) injury. Drug-induced hepatic injuries were associated with an risk of elevated need for a liver transplant, or even death, with the incidence of severe liver damage was shown to be approximately 1 in 250,000 to 300,000 patient-years. On May 20, 2004, Bristol-Myers Squibb discontinued the sale of Serzone in the United States.
Background
Nefazodone hydrochloride (trade name Serzone) is an antidepressant drug marketed by Bristol-Myers Squibb. Its sale was discontinued in 2003 in some countries, due to the small possibility of hepatic (liver) injury. Drug-induced hepatic injuries were associated with an risk of elevated need for a liver transplant, or even death, with the incidence of severe liver damage was shown to be approximately 1 in 250,000 to 300,000 patient-years. On May 20, 2004, Bristol-Myers Squibb discontinued the sale of Serzone in the United States.
Indication
用于抑郁症的治疗。
Associated Conditions
- Depression
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2005/11/07 | Phase 2 | Completed | |||
2005/10/04 | Phase 4 | Completed | |||
2001/04/18 | Phase 2 | Completed | |||
1999/09/21 | Phase 2 | Completed | |||
1999/09/21 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Pharmaceuticals USA, Inc. | 0093-1025 | ORAL | 200 mg in 1 1 | 11/16/2021 | |
| Rebel Distributors Corp | 21695-176 | ORAL | 200 mg in 1 1 | 11/29/2006 | |
| STAT RX USA LLC | 16590-166 | ORAL | 100 mg in 1 1 | 4/7/2011 | |
| Rebel Distributors Corp | 21695-175 | ORAL | 150 mg in 1 1 | 11/29/2006 | |
| Rebel Distributors Corp | 21695-177 | ORAL | 250 mg in 1 1 | 11/29/2006 | |
| Teva Pharmaceuticals USA, Inc. | 0093-1026 | ORAL | 250 mg in 1 1 | 11/16/2021 | |
| Teva Pharmaceuticals USA, Inc. | 0093-7113 | ORAL | 150 mg in 1 1 | 11/16/2021 | |
| Rebel Distributors Corp | 21695-174 | ORAL | 100 mg in 1 1 | 11/29/2006 | |
| Teva Pharmaceuticals USA, Inc. | 0093-7178 | ORAL | 50 mg in 1 1 | 11/16/2021 | |
| Teva Pharmaceuticals USA, Inc. | 0093-1024 | ORAL | 100 mg in 1 1 | 11/16/2021 |
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. | |||||