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SERZONE

NDA

NEFAZODONE HYDROCHLORIDE | N020152 | BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE

6 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizens Petition from Public Citizen FDA-2003-P-0336 · 6 docket documents Public Citizen petitioned the FDA on March 6, 2003, pursuant to 21 U.S.C. Section 355(e)(3), to immediately withdraw nefazodone (Serzone) manufactured by Bristol-Myers Squibb from the U.S. market due to serious hepatotoxicity, citing at least 53 cases of liver injury including 21 cases of liver fail	Other	2009-04-16	Denied	Public Citizen

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

5 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10 NCT00000293	Phase 3	Completed	National Institute on Drug Abuse (NIDA)	—	1999-01 → 2001-12
Nefazodone in the Treatment of Cocaine Dependence and Depression - 4 NCT00015210	Phase 2	Completed	Boston Medical Center	69	1997-02
Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3 NCT00000286	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	—	1996-12 → 2001-12
Nefazodone in the Treatment of Social Phobia NCT00231348	Phase 4	Completed	Emory University	24	— → 2000-04
Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals NCT00249509	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	132	2000-09 → 2004-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TAPI NL BVNEFAZODONE HYDROCHLORIDE USP

DMF 142791999

SIGNA SA DE CVInactiveNEFAZODONE HYDROCHLORIDE

DMF 163872003

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jan 13, 2005	SUPPL -35	View Letter (PDF)
Jun 1, 2004	SUPPL -34	View Letter (PDF)
May 30, 2003	SUPPL -31	View Letter (PDF)
Jun 20, 2002	SUPPL -33	View Letter (PDF)
Jan 8, 2002	SUPPL -29	View Letter (PDF)
Dec 4, 2001	SUPPL -28	View Letter (PDF)
Mar 21, 2001	SUPPL -26	View Letter (PDF)
Mar 31, 1998	SUPPL -11	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

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#001 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

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