[Federal Register Volume 63, Number 32 (Wednesday, February 18, 1998)]
[Rules and Regulations]
[Pages 8122-8123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3984]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Difloxacin 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 new animal drug application 
(NADA) filed by Fort Dodge Animal Health. The NADA provides for oral 
use of difloxacin tablets for management of diseases in dogs associated 
with bacteria susceptible to difloxacin.

EFFECTIVE DATE: February 18, 1998.
FOR FURTHER INFORMATION CONTACT: Tania D. Woerner, Center for 
Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1617.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of 
American Home Products, 800 Fifth St. NW., P.O. Box 518, Fort Dodge, IA 
50501, filed NADA 141-096 that provides for oral use of 
Dicural (difloxacin) tablets for management of diseases in 
dogs associated with bacteria susceptible to difloxacin. The drug is 
limited to use by or on the order of a licensed veterinarian. The NADA 
is approved as of November 20, 1997, and the regulations are amended by 
adding new Sec. 520.645 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.
    Under section 512(c)(2)(F)(iv) of the Federal Food, Drug, and 
Cosmetic Act

[[Page 8123]]

(the act), this approval, which is solely for nonfood-producing animals 
qualifies for 3 years of marketing exclusivity beginning November 20, 
1997, because the applicant has elected to waive section 
512(c)(2)(F)(i) of the act.
    FDA has determined under 21 CFR 25.33(d) 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.

List of Subjects in 21 CFR Part 520

    Animal drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the 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: 21 U.S.C. 360b.

    2. Section 520.645 is added to read as follows:

Sec. 520.645  Difloxacin.

    (a) Specifications. Each tablet contains 11.4, 45.4, or 136 
milligrams (mg) of difloxacin hydrochloride.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 5 to 10 mg per 
kilogram (2.3 to 4.6 mg/pound) of body weight.
    (ii) Indications for use. For management of diseases in dogs 
associated with bacteria susceptible to difloxacin.
    (iii) Limitations. Use once a day for 2 to 3 days beyond cessation 
of clinical signs of disease up to a maximum of 30 days. Federal law 
prohibits the extra-label use of this drug in food-producing animals. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) [Reserved]

    Dated: January 21, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-3984 Filed 2-17-98; 8:45 am]
BILLING CODE 4160-01-F