Nefazodone

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.

Indication

用于抑郁症的治疗。

Associated Conditions

Depression

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals	2005/11/07	NCT00249509	Phase 2	Completed	National Institute on Drug Abuse (NIDA)
Nefazodone in the Treatment of Social Phobia	2005/10/04	NCT00231348	Phase 4	Completed	Emory University
Nefazodone in the Treatment of Cocaine Dependence and Depression - 4	2001/04/18	NCT00015210	Phase 2	Completed	Boston Medical Center
Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3	1999/09/21	NCT00000286	Phase 2	Completed	National Institute on Drug Abuse (NIDA)
Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10	1999/09/21	NCT00000293	Phase 3	Completed	National Institute on Drug Abuse (NIDA)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Nefazodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	0093-1025	ORAL	200 mg in 1 1	11/16/2021
Nefazodone Hydrochloride	Rebel Distributors Corp	21695-176	ORAL	200 mg in 1 1	11/29/2006
NEFAZODONE HYDROCHLORIDE	STAT RX USA LLC	16590-166	ORAL	100 mg in 1 1	4/7/2011
Nefazodone Hydrochloride	Rebel Distributors Corp	21695-175	ORAL	150 mg in 1 1	11/29/2006
Nefazodone Hydrochloride	Rebel Distributors Corp	21695-177	ORAL	250 mg in 1 1	11/29/2006
Nefazodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	0093-1026	ORAL	250 mg in 1 1	11/16/2021
Nefazodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	0093-7113	ORAL	150 mg in 1 1	11/16/2021
Nefazodone Hydrochloride	Rebel Distributors Corp	21695-174	ORAL	100 mg in 1 1	11/29/2006
Nefazodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	0093-7178	ORAL	50 mg in 1 1	11/16/2021
Nefazodone Hydrochloride	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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
LIN-NEFAZODONE	linson pharma co.	02237398	Tablet - Oral	100 MG / TAB	9/11/2000
SERZONE-5HT2	bristol-myers squibb canada	02087294	Tablet - Oral	50 MG	7/16/1997
LIN-NEFAZODONE	linson pharma co.	02237397	Tablet - Oral	50 MG / TAB	9/11/2000
SERZONE-5HT2	bristol-myers squibb canada	02087375	Tablet - Oral	100 MG	12/31/1994
SERZONE-5HT2	bristol-myers squibb canada	02087391	Tablet - Oral	200 MG	12/31/1994
LIN-NEFAZODONE	linson pharma co.	02237400	Tablet - Oral	200 MG / TAB	9/11/2000
LIN-NEFAZODONE	linson pharma co.	02237399	Tablet - Oral	150 MG / TAB	9/11/2000
SERZONE-5HT2	bristol-myers squibb canada	02087383	Tablet - Oral	150 MG	12/31/1994

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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