[Federal Register Volume 69, Number 87 (Wednesday, May 5, 2004)]
[Rules and Regulations]
[Pages 24958-24959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10210]


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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, Division of 
Wyeth. The supplemental NADA provides for oral use of moxidectin gel in 
horses and ponies for the treatment and control of an additional 
species of small strongyle.

DATES: This rule is effective May 5, 2004.

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, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 
141-087 for QUEST (moxidectin 2.0%) Gel, used for the treatment and 
control of various species of internal parasites in horses and ponies. 
The supplemental NADA provides for the addition of one new species of 
adult small strongyle and for the speciation of adult small strongyles 
in product labeling. The supplemental NADA is approved as of March 17, 
2004, and 21 CFR 520.1452 is amended to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Division of Dockets Management 
(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.
    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 approval qualifies 
for 3 years of marketing exclusivity beginning March 17, 2004. 
Exclusivity applies only to the new effectiveness claim for adult 
Coronocyclus labratus for which new data were required.
    The agency has determined under 21 CFR 25.33(d)(1) 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 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.

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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:

[[Page 24959]]

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

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2. Section 520.1452 is amended by revising the heading of paragraph (d) 
and by revising paragraph (d)(2) to read as follows:


Sec.  520.1452  Moxidectin gel.

* * * * *
    (d) Conditions of use in horses and ponies--* * *
    (2) Indications for use. For the treatment and control of large 
strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. 
edentatus (adult and tissue stages), Triodontophorus brevicauda 
(adults), and T. serratus (adults); small strongyles (adults):  
Cyathostomum spp., including C. catinatum and C. pateratum; 
Cylicocyclus. spp., including C. insigne, C. leptostomum, and C. 
nassatus; Cyliocostephanus. spp., including C. calicatus, C. goldi, C. 
longibursatus, and C. minutus; Coronocyclus spp., including C. 
coronatus, C. labiatus, and C. labratus; and Gyalocephalus capitatus; 
small strongyles: 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.
* * * * *

    Dated: April 14, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-10210 Filed 5-4-04; 8:45 am]
BILLING CODE 4160-01-S