97-19125. Oral Dosage Form New Animal Drugs; Enrofloxacin Tablets  

  • [Federal Register Volume 62, Number 139 (Monday, July 21, 1997)]
    [Rules and Regulations]
    [Pages 38906-38907]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-19125]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 520
    
    
    Oral Dosage Form New Animal Drugs; Enrofloxacin Tablets
    
    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 Bayer Corp., Agriculture Division, Animal 
    Health. The supplemental NADA provides for revised conditions for use 
    (dose, indications, and limitations) of enrofloxacin tablets in dogs 
    and cats for the management of diseases associated with bacteria 
    susceptible to enrofloxacin.
    
    EFFECTIVE DATE: July 21, 1997.
    
    FOR FURTHER INFORMATION CONTACT: Linda M. Wilmot, Center for Veterinary 
    Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
    Rockville, MD 20855, 301-594-0614.
    
    SUPPLEMENTARY INFORMATION: Bayer Corp., Agriculture Division, Animal 
    Health, P.O. Box 390, Shawnee Mission, KS 66201, filed supplemental 
    NADA 140-441 Baytril Tablets (5.7, 22.7, or 68.0 milligrams 
    (mg) enrofloxacin). The supplemental NADA provides for revised 
    conditions for use of enrofloxacin in dogs and cats for management of 
    diseases associated with bacteria susceptible to enrofloxacin by 
    administering the tablets orally at a rate of 5 to 20 mg per kilogram 
    (2.27 to 9.07 mg/pounds) of body weight as a single daily dose or 
    divided and given in 2 equal daily doses at 12 hour intervals for at 
    least 2 to 3 days beyond cessation of clinical signs, to a maximum of 
    30 days. The supplemental NADA is approved as of June 19, 1997, and the 
    regulations are amended in Sec. 520.812 (21 CFR 520.812) by 
    redesignating paragraph (c) as paragraph (d) and by reserving new 
    paragraph (c) to provide for more uniform regulations and future 
    expansion. Newly redesignated Sec. 520.812(d) is revised to reflect the 
    approval. The basis for approval is discussed in the freedom of 
    information summary.
        In accordance with the freedom of information provisions of 21 CFR 
    part 20 and 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 Dockets Management Branch (HFA-305), Food and Drug 
    Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
    between 9 a.m. and 4 p.m., Monday through Friday.
        The agency has carefully considered the potential environmental 
    effects of this action. FDA has concluded that the action will not have 
    a significant impact on the human environment, and that an 
    environmental impact statement is not required. The agency's finding of 
    no significant impact and the evidence supporting that finding, 
    contained in an environmental assessment, may be seen in the Dockets 
    Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
    through Friday.
    
    List of Subjects in 21 CFR Part 520
    
        Animal drugs.
        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 520 is 
    amended as follows:
    
    PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
    
        1. The authority citation for 21 CFR part 520 continues to read as 
    follows:
    
        Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
    (21 U.S.C. 360b).
    
        2. Section 520.812 is amended by redesignating existing paragraph 
    (c) as paragraph (d), by reserving paragraph (c), and by revising newly 
    redesignated paragraph (d) to read as follows:
    
    
    Sec. 520.812  Enrofloxacin tablets.
    
    * * * * *
        (c) [Reserved]
        (d) Conditions of use. (1) Amount. 5 to 20 milligrams per kilogram 
    (2.27 to 9.07 milligrams per pound) of body weight.
        (2) Indications for use. Dogs and cats for management of diseases 
    associated with bacteria susceptible to enrofloxacin.
    
    [[Page 38907]]
    
        (3) Limitations. Administer orally as a single dose or divided into 
    2 equal doses at 12 hour intervals, daily. Administer for at least 2 to 
    3 days beyond cessation of clinical symptoms, for a maximum of 30 days. 
    Safety in breeding or pregnant cats has not been established. Federal 
    law restricts this drug to use by or on the order of a licensed 
    veterinarian.
    
        Dated: July 9, 1997.
    Stephen F. Sundlof,
    Director, Center for Veterinary Medicine.
    [FR Doc. 97-19125 Filed 7-18-97; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
7/21/1997
Published:
07/21/1997
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
97-19125
Dates:
July 21, 1997.
Pages:
38906-38907 (2 pages)
PDF File:
97-19125.pdf
CFR: (1)
21 CFR 520.812