[Federal Register Volume 62, Number 154 (Monday, August 11, 1997)]
[Rules and Regulations]
[Pages 42902-42903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21086]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Moxidectin Gel

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 gel for horses and ponies for treatment and control 
of infections of certain gastrointestinal parasites.

EFFECTIVE DATE: August 11, 1997.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1612.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of 
American Home Products Corp., 800 Fifth Street NW., P.O. Box 518, Fort 
Dodge, IA 50501, filed original NADA 141-087 that provides for use of 
QuestTM moxidectin 2 percent oral gel in horses and ponies 
at 0.4 milligram moxidectin per kilogram of body weight for treatment 
and control of infections of certain large strongyles, small strongyles 
(adult and larvae), encysted cyathostomes, ascarids, pinworms, 
hairworms, large-mouth stomach worms, and horse stomach bots, and for 
supression of small strongyle egg production for 84 days. The NADA is 
approved as of July 11, 1997, and the regulations are amended by adding 
new 21 CFR 520.1452 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)(ii) of the Federal Food, Drug, and 
Cosmetic Act, this approval qualifies for 3 years of marketing 
exclusivity beginning July 11, 1997, because the application contains 
substantial evidence of the effectiveness of the drug involved, any 
studies of animal safety or, in the case of food-producing animals, 
human food safety studies (other than bioequivalence or residue 
studies) required for approval of the application and conducted or 
sponsored by the applicant.
    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 
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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. New Sec. 520.1452 is added to read as follows:

Sec. 520.1452  Moxidectin gel.

    (a) Specifications. The gel contains 2 percent moxidectin (20 
milligrams per milliliter).
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. 0.4 milligram moxidectin per 
kilogram (2.2 pounds) of body weight.
    (2) Indications for use. Horses and ponies for treatment and 
control of large strongyles (Strongylus vulgaris (adults and L4/L5 
arterial stages), S. edentatus (adult and tissue stages), 
Triodontophorus brevicauda (adults), T. serratus (adults)); small 
strongyles (Cyathostomum spp. (adults), Cylicocyclus spp. (adults), 
Cylicostephanus spp. (adults), Gyalocephalus capitatus (adults), 
undifferentiated lumenal larvae); encysted cyathostomes (late L3 and L4 
mucosal cyathostome larvae); ascarids (Parascaris equorum (adults and 
L4 larval stages)); pinworms (Oxyuris equi (adults and L4 larval 
stages)), hairworms (Trichostrongylus axei (adults)), large-

[[Page 42903]]

mouth stomach worms (Habronema muscae (adults)), and horse stomach bots 
(Gasterophilus intestinalis (2nd and 3rd instars)). One dose also 
supresses small strongyle egg production for 84 days.
    (3) Limitations. For horses and ponies including breeding mares and 
stallions. Not for use in horses and ponies intended for food. Consult 
your veterinarian for assistance in the diagnosis, treatment, and 
control of parasitism.

    Dated: August 1, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-21086 Filed 8-8-97; 8:45 am]
BILLING CODE 4160-01-F