[Federal Register Volume 64, Number 226 (Wednesday, November 24, 1999)]
[Rules and Regulations]
[Pages 66104-66105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30571]
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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 Gel
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 Fort Dodge Animal Health. The supplemental
NADA provides for oral use of moxidectin gel for horses and ponies for
treatment and control of Gasterophilus nasalis (3rd instars)
infections.
EFFECTIVE DATE: November 24, 1999.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7543.
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Div. of American
Home Products Corp., 800 5th St. NW, P.O. Box 518, Fort Dodge, IA
50501, filed supplemental NADA 141-087 that provides for use of
QuestTM moxidectin 2-percent equine oral gel in horses and
ponies for treatment and control of horse stomach bot G. nasalis (3rd
instars). The product is approved 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 (G. intestinalis (2nd and
3rd instars)), and for suppression of strongyle egg production for 84
days. The supplemental NADA is approved as of October 4, 1999, and the
regulations are amended in 21 CFR 520.1452(d)(2) to reflect the
approval. The basis for approval is discussed in the freedom of
information summary.
Also, Sec. 520.1452 is amended in paragraph (d)(2) to state that
the drug will suppress strongyle egg production for 84 days, and
paragraph (d)(3) is amended to remove statements required elsewhere by
the regulations or not required to be codified.
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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday, except on Federal
holidays.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act, this approval for nonfood producing animals qualifies for
3 years of marketing exclusivity beginning October 4, 1999, because the
application contains substantial evidence of the effectiveness of the
drug involved or any studies of animal safety required for approval of
the application and conducted or sponsored by the applicant. The 3
years of marketing exclusivity applies only to use for treatment and
control of horse stomach bot G. nasalis (3rd instars) infections.
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
[[Page 66105]]
environmental impact statement is required.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
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 520.1452 is amended by revising paragraphs (d)(2) and
(d)(3) to read as follows:
Sec. 520.1452 Moxidectin gel.
* * * * *
(d) * * *
(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-mouth
stomach worms (Habronema muscae (adults)); and horse stomach bots
(Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd
instars)). One dose also suppresses strongyle egg production for 84
days.
(3) Limitations. Not for use in horses and ponies intended for
food.
Dated: November 12, 1999.
Melanie R. Berson,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 99-30571 Filed 11-23-99; 8:45 am]
BILLING CODE 4160-01-F
