Notice of Approval of New Animal Drug Application; Ceftiofur

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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: melanie.berson@fda.gov.

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.