[Federal Register Volume 60, Number 2 (Wednesday, January 4, 1995)]
[Rules and Regulations]
[Page 362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-164]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Lufenuron 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 Ciba Animal Health, Ciba-Geigy Corp. The NADA provides 
for oral administration of lufenuron tablets to dogs for the prevention 
and control of flea populations.

EFFECTIVE DATE: January 4, 1995.

FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for 
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0614.

SUPPLEMENTARY INFORMATION: Ciba Animal Health, Ciba-Geigy Corp., P.O. 
Box 18300, Greensboro, NC 27419-8300, filed NADA 141-035, which 
provides for oral administration of Program tablets 
containing 45, 90, 204.9, or 409.8 milligrams (mg) of lufenuron per (/) 
tablet. Once a month, Program tablets are administered to 
dogs, 6 weeks of age and older, at a minimum dosage of 10 mg of 
lufenuron/kilogram (4.5 mg/pound) of body weight for the prevention and 
control of flea populations. The drug has no deleterious effect on 
adult fleas, but it prevents most flea eggs from maturing into adults. 
The NADA is approved as of November 23, 1994, and the regulations are 
amended in part 520 (21 CFR part 520) by adding new Sec. 520.1288 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 part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    Section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act 
provides a 5-year period of exclusivity to this original NADA beginning 
November 23, 1994, because no active ingredient (including any ester or 
salt of the active ingredient) has been approved in any other 
application under section 512(b)(1) of the act.
    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. New Sec. 520.1288 is added to read as follows:


Sec. 520.1288  Lufenuron tablets.

    (a) Specifications. Each tablet contains either 45, 90, 204.9, or 
409.8 milligrams of lufenuron.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 10 milligrams of lufenuron per 
kilogram (4.5 milligrams per pound) of body weight.
    (2) Indications for use. For use in dogs, 6 weeks of age and older, 
for the prevention and control of flea populations.
    (3) Limitations. Administer tablet(s) after or in conjunction with 
a full meal to ensure adequate absorption. Administer tablet(s) once a 
month, preferably on same date each time. All dogs in a household 
should be treated to achieve maximum efficacy. Because the drug has no 
affect on adult fleas, the concurrent use of insecticides that kill 
adults may be required depending on the severity of the infestation. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: December 23, 1994.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-164 Filed 1-3-95; 8:45 am]
BILLING CODE 4160-01-F