Document ID: FDA-2010-N-0002-0001
Agency: fda
Document Type: Notice
Title: Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid
Posted Date: 2010-01-29T05:00Z

[Federal Register: January 29, 2010 (Volume 75, Number 19)]
[Rules and Regulations]               
[Page 4692]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ja10-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2010-N-0002]

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Ceftiofur Crystalline Free Acid

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 supplemental new animal drug 
application (NADA) filed by Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc. The supplemental NADA provides for veterinarian 
prescription use of ceftiofur crystalline free acid injectable 
suspension for the treatment of lower respiratory tract infections in 
horses.

DATES:  This rule is effective January 29, 2010.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement 
to NADA 141-209 for EXCEDE (ceftiofur crystalline free acid) Sterile 
Suspension. The supplemental NADA provides for veterinarian 
prescription use of ceftiofur crystalline free acid injectable 
suspension for the treatment of lower respiratory tract infections in 
horses caused by susceptible strains of Streptococcus equi ssp. 
zooepidemicus. The application is approved as of December 16, 2009, and 
the regulations are amended in 21 CFR 522.313a to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of the safety and 
effectiveness data and information submitted to support approval of 
these applications 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)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning on the date of 
approval.
    The agency has determined under 21 CFR 25.33 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 Subjects in 21 CFR Part 522

    Animal drugs.

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

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

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

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2. In Sec.  522.313a, add paragraph (e)(3) to read as follows:

Sec.  522.313a  Ceftiofur crystalline free acid.

* * * * *
    (e) * * *
    (3) Horses--(i) Amount. Two intramuscular injections, 4 days apart, 
at a dose of 3.0 mg/lb (6.6 mg/kg) body weight.
    (ii) Indications for use. For the treatment of lower respiratory 
tract infections in horses caused by susceptible strains of 
Streptococcus equi ssp. zooepidemicus.
    (iii) Limitations. Do not use in horses intended for human 
consumption.

    Dated: January 22, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-1790 Filed 1-28-10; 8:45 am]
BILLING CODE 4160-01-S