[Federal Register Volume 62, Number 135 (Tuesday, July 15, 1997)]
[Rules and Regulations]
[Pages 37712-37713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18457]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Moxidectin 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 moxidectin tablets for dogs to prevent canine heartworm 
infections and subsequent development of canine heartworm disease.

EFFECTIVE DATE: July 15, 1997.

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.


[[Page 37713]]


SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Div. of American 
Home Products Corp., 800 Fifth St. NW., P.O. Box 518, Fort Dodge, IA 
50501, filed original NADA 141-051 that provides for oral use of 
ProHeartTM (moxidectin) tablets in dogs to prevent 
infections by the canine heartworm Dirofilaria immitis and the 
subsequent development of canine heartworm disease. The drug is limited 
to use by or on the order of a licensed veterinarian.
    The NADA is approved as of May 27, 1997, and the regulations are 
amended by adding new 21 CFR 520.1451 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)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning May 27, 1997, because no 
active ingredient of the drug, including any ester or salt of the 
active ingredient, has been previously approved in any other 
application filed under 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. 520.1451 is added to read as follows:

Sec. 520.1451  Moxidectin.

    (a) Specifications. Each tablet contains 30, 68, or 136 micrograms 
of moxidectin.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. 3 micrograms per kilogram (1.36 
micrograms per pound) of body weight.
    (2) Indications for use. To prevent infection by the canine 
heartworm Dirofilaria immitis and the subsequent development of canine 
heartworm disease.
    (3) Limitations. Use once-a-month in dogs at 8 weeks of age or 
older. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

    Dated: June 20, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-18457 Filed 7-14-97; 8:45 am]
BILLING CODE 4160-01-F