Document ID: FDA-2008-N-0039-0062
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Hydrochloride
Posted Date: 2008-08-06T04:00Z

[Federal Register: August 6, 2008 (Volume 73, Number 152)]
[Rules and Regulations]               
[Page 45611-45612]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au08-7]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2008-N-0039]

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Ceftiofur Hydrochloride

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Pharmacia and Upjohn Co., a Division of Pfizer, Inc. 
The NADA provides for the veterinary prescription use of a ceftiofur 
hydrochloride injectable suspension for treatment of various bacterial 
infections in swine and cattle.

DATES: This rule is effective August 6, 2008.

FOR FURTHER INFORMATION CONTACT: Donald A. Prater, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail: 
donald.prater@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed NADA 141-288 
that provides for veterinary prescription use of EXCENEL RTU EZ 
(ceftiofur hydrochloride) Sterile Suspension, used for treatment of 
various bacterial infections in swine and cattle. The NADA is approved 
as of July 1, 2008, and the regulations are amended in 21 CFR 522.313b 
to reflect the approval. A swine pathogen is also being revised to 
reflect current scientific nomenclature.
    In accordance with the freedom of information 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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning on the date of approval.
    The agency has determined under Sec.  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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subject in 21 CFR Part 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under

[[Page 45612]]

authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  522.313b, revise paragraphs (a), (e)(1)(ii), and (e)(2)(i) 
to read as follows:

Sec.  522.313b  Ceftiofur hydrochloride.

    (a) Specifications. Each milliliter of ceftiofur hydrochloride 
suspension contains 50 milligrams (mg) ceftiofur equivalents in either 
a peanut oil or caprylic/capric triglyceride suspension.
* * * * *
    (e) Conditions of use--
    (1) * * *
    (ii) Indications for use. For treatment and control of swine 
bacterial respiratory disease (swine bacterial pneumonia) associated 
with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella 
Choleraesuis, and Streptococcus suis.
* * * * *
    (2) * * *
    (i) Amount. For bovine respiratory disease and acute bovine 
interdigital necrobacillosis, administer 1.1 to 2.2 mg/kg of body 
weight at 24-hour intervals for 3 to 5 consecutive days. For bovine 
respiratory disease only, 2.2 mg/kg of body weight may be administered 
twice at a 48-hour interval. For acute metritis only, administer 2.2 
mg/kg of body weight at 24-hour intervals for 5 consecutive days. 
Product in peanut oil suspension may be administered by either 
intramuscular or subcutaneous injection. Product in caprylic/capric 
triglyceride suspension may be administered by subcutaneous injection 
only.
* * * * *

    Dated: July 28, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-18094 Filed 8-5-08; 8:45 am]

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