[Federal Register Volume 60, Number 188 (Thursday, September 28, 1995)]
[Rules and Regulations]
[Pages 50096-50097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24160]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Milbemycin Oxime

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 Ciba-Geigy Animal Health, Ciba-Geigy Corp. 
The supplemental NADA provides for the use of milbemycin oxime tablets 
in puppies 4 weeks of age or greater and 2 pounds (lb) of body weight 
or greater for the prevention of heartworm disease, control of adult 
hookworm infections, and removal and control of adult roundworm and 
whipworm infections.

EFFECTIVE DATE: September 28, 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-Geigy Animal Health, Ciba-Geigy Corp., 
P.O. Box 18300, Greensboro, NC 27419-8300, filed a supplement to NADA 
140-915 for INTERCEPTOR (milbemycin oxime) tablets. The NADA 
provides for veterinary prescription use of 2.3-,
 5.75-, 11.5-, and 23.0-milligrams INTERCEPTOR tablets for 
use as an anthelmintic in dogs in the prevention of heartworm disease 
caused by Dirofilaria immitis, control of adult Ancylostoma caninum 
(hookworm), removal and control of adult Toxocara canis (roundworm), 
and Trichuris vulpis (whipworm) infections in dogs. The supplement 
provides for use of the product to treat puppies 4 weeks of age or 
greater and 2 lb of body weight or greater for the same infections.
    The supplemental NADA 140-915 is approved as of August 16, 1995, 
and the regulations are amended by revising 21 CFR 520.1445(c)(2) and 
(c)(3) to reflect 

[[Page 50097]]
the approval. The basis of 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.
    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 for the new indications 
beginning August 16, 1995, because new clinical or field investigations 
(other than bioequivalence or residue studies) conducted by the sponsor 
were required for the approval.
    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).


Sec. 520.1445  [Amended]

    2. Section 520.1445 Milbemycin oxime tablets is amended in 
paragraph (c)(2) by adding the phrase ``and in puppies 4 weeks of age 
or greater and 2 pounds of body weight or greater.'' at the end of the 
paragraph and in paragraph (c)(3) by adding the sentence ``Do not use 
in puppies less than 4 weeks of age and less than 2 pounds in body 
weight.'' at the beginning of the paragraph.

    Dated: September 15, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 95-24160 Filed 9-27-95; 8:45 am]
BILLING CODE 4160-01-F