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CLAFORAN

NDA

CEFOTAXIME SODIUM | N050547 | STERIMAX INC

4 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Cardinal Health Regulatory Sciences FDA-2019-P-1366 · 4 docket documents Cardinal Health Regulatory Sciences filed this citizen petition pursuant to 21 CFR 10.30 and 21 CFR 314.161 requesting that the FDA Commissioner determine whether CLAFORAN (Cefotaxime Sodium for Injection in 500 mg, 1g, 2g, and 10g/vial strengths, NDA 050547) held by US Pharmaceutical Holdings II LL	505(q)	2019-03-22	Granted	Cardinal Health Regulatory Sciences
Hospira, Inc. - Citizen Petition FDA-2011-P-0173 · 4 docket documents Hospira, Inc. filed this citizen petition on March 17, 2011, requesting that the FDA designate Sanofi-Aventis's CLAFORAN (Cefotaxime for Injection) 1g and 2g in ADD-Vantage Vial, ANDA 062659, as an additional Reference Listed Drug under Section 505(j) of the Federal Food, Drug and Cosmetic Act to en	505(q)	2011-03-25	Granted	—

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

Clinical Trials

18 trials from ClinicalTrials.gov — 1 recruiting, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis NCT04168099	Phase 3	Recruiting	Tanta University	60	2018-12-01 → 2028-12-30
Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients NCT02389036	Phase 3	Completed	The George Institute	20,010	2017-05-01 → 2023-04-26
Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis NCT01551394	Phase 3	Completed	PENTA Foundation	272	2012-09 → 2014-12
Effect of, OAT3, on the Renal Secretion of Cefotaxime NCT00187655	Phase 1	Completed	University of California, San Francisco	24	2004-01 → 2013-12
Impact of Cefotaxime and Ceftriaxone on the Emergence and Carrying of Multidrug-Resistant Bacteria NCT03903783	N/A	Completed	Fondation Hôpital Saint-Joseph	34	2019-04-30 → 2021-08-13
Antibiotic "Dysbiosis" in Preterm Infants NCT02784821	Phase 2	Completed	University of Florida	98	2017-01-16 → 2019-09-11
Impact of the Choice of 3rd Generation Cephalosporins on the Emergence of Resistance in the Microbiota Intestinal.NCT02659033	Phase 3	Completed	Assistance Publique - Hôpitaux de Paris	22	2016-03 → 2017-12
Early-onset Ventilator-associated Pneumonia in Adults: Comparison of 8 Versus 15 Days of Antibiotic Treatment NCT01559753	Phase 4	Completed	Centre Hospitalier Universitaire de Besancon	225	1998-01 → 2002-11
Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of SBP in Patients With LC NCT01265173	Phase 4	Completed	Korea University	261	2007-04 → 2018-06
Cerebral Antibiotics Distribution After Acute Brain Injury NCT01059890	Phase 1	Completed	Poitiers University Hospital	18	2009-09

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

API Supply Chain6 active DMFs5 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

ACS DOBFAR SPACEFOTAXIME SODIUM STERILE

DMF 143671999

ORCHID PHARMA LTDCEFOTAXIME SODIUM, USP (STERILE BULK)

DMF 178882004

SANDOZ GMBHCEFOTAXIME SODIUM STERILE

DMF 212022007

NECTAR LIFESCIENCES LTDCEFOTAXIME (NON STERILE DRUG SUBSTANCES INTERMEDIATE)

DMF 243402010

NECTAR LIFESCIENCES LTDCEFOTAXIME SODIUM USP (STERILE) DRUG SUBSTANCE

DMF 247482011

SHANDONG ANHONG PHARMACEUTICAL CO LTDCEFOTAXIME SODIUM

DMF 417322025

WOCKHARDT LTDInactiveCEFOTAXIME SODIUM (STERILE)

DMF 168392003

AUROBINDO PHARMA LTDInactiveCEFOTAXIME SODIUM (STERILE)

DMF 181542005

KYONGBO PHARMACEUTICAL CO LTDInactiveCEFOTAXIME SODIUM, STERILE API

DMF 247932011

CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTDInactiveCEFOTAXIME SODIUM STERILE

DMF 248922011

ZHUHAI UNITED LABORATORIES CO LTDInactiveCEFOTAXIME SODIUM USP

DMF 258442012

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Mar 24, 2015	SUPPL -71	View Letter (PDF)
Feb 25, 2014	SUPPL -70	View Letter (PDF)
Sep 13, 2011	SUPPL -68	View Letter (PDF)
Jun 2, 2009	SUPPL -67	View Letter (PDF)
Feb 25, 2008	SUPPL -66	View Letter (PDF)
Sep 3, 2004	SUPPL -61	View Letter (PDF)
Jun 24, 2004	SUPPL -60	View Letter (PDF)
Jan 18, 2002	SUPPL -47	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 29, 1983