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ZEFAZONE IN PLASTIC CONTAINER

NDA

CEFMETAZOLE SODIUM | N050683 | PHARMACIA AND UPJOHN CO

2 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Salus Pharma LLC - Citizen Petition FDA-2013-P-0768 · 5 docket documents Salus Pharma LLC filed this citizen petition on June 17, 2013, requesting that the FDA Commissioner determine whether Zefazone (cefmetazole sodium) injection in 1 gram and 2 gram base per vial formulations were voluntarily withdrawn from sale for safety or efficacy reasons, as required under 21 CFR	505(q)	2013-07-12	Granted	—

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

Clinical Trials

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery NCT00292708	Phase 3	Completed	National Cancer Center, Japan	500	2004-05 → 2005-07
Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics NCT00508690	Phase 3	Completed	Japan Multinational Trial Organization	584	2007-09 → 2011-12

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

API Supply Chain1 active DMF2 inactive

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

SUZHOU HOMESUN PHARMACEUTICAL CO LTDCEFMETAZOLE SODIUM

DMF 273812013

SANKYO CO LTDInactiveCEFMETAZOLE SODIUM INJECTION(VIALS)

DMF 59521985

SANKYO CO LTDInactiveCEFMETAZOLE (FREE ACID)

DMF 98871982

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

Products (2)

Sort:

#001 — EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 29, 1992

No patent or exclusivity listings for this strength.

#002 — EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 29, 1992