[Federal Register Volume 69, Number 73 (Thursday, April 15, 2004)]
[Notices]
[Page 20012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8513]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Notice of Approval of New Animal Drug Application; Ceftiofur

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is providing notice 
that it has approved a supplemental new animal drug application (NADA) 
filed by Pharmacia &Upjohn, Co. The supplemental NADA provided revised 
susceptibility information for equine pathogens listed in the clinical 
microbiology section of labeling for ceftiofur sodium sterile powder 
for injection and added interpretive criteria. The applicable section 
of the regulations did not require amendment.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn, Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed a supplement to NADA 140-338 which 
provides for the veterinary prescription use of NAXCEL (ceftiofur 
sodium) Sterile Powder for Injection. The supplemental NADA provided 
updated susceptibility data for equine respiratory pathogens listed in 
the clinical microbiology section of labeling and added the National 
Committee for Clinical Laboratory Standards' interpretive criteria for 
equine isolates. In accordance with section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(i)) and 21 CFR 514.105(a) and 
514.106(a), FDA is providing notice that this supplemental NADA is 
approved as of February 27, 2004. The basis of approval is discussed in 
the freedom of information (FOI) summary.
    In accordance with the FOI provisions of 21 CFR part 20 and 21 CFR 
514.11(e)(2)(ii), a summary of safety and effectiveness data and 
information submitted to support approval of this application may be 
seen in the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

    Dated: March 19, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-8513 Filed 4-14-04; 8:45 am]
BILLING CODE 4160-01-S