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Oral Dosage Form New Animal Drugs; Ivermectin Meal

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: January 11, 2005 (Volume 70, Number 7)]
[Rules and Regulations]
[Page 1817-1818]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja05-5]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
 
Oral Dosage Form New Animal Drugs; Ivermectin Meal

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 Merial, Ltd. The NADA provides for use of ivermectin 
meal for the control of various species of internal parasites in horses.

DATES: This rule is effective January 11, 2005.

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: 
melanie.berson@fda.gov.

SUPPLEMENTARY INFORMATION: Merial, Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640, filed NADA 141-241 for ZIMECTERIN-EZ 
(ivermectin) 0.6% w/w for Horses. The application provides for use of 
ivermectin meal for the control of various species of internal 
parasites in horses. The NADA is approved as of December 16, 2004, and 
part 520 (21 CFR part 520) is amended by adding new Sec.  520.1194 to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    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)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning December 16, 2004.
    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.

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

? 2. Section 520.1194 is added to read as follows:

Sec.  520.1194  Ivermectin meal.

    (a) Specifications. Each gram of meal contains 6 milligrams 
ivermectin (0.6 percent).
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. See Sec.  500.25 of this chapter.
    (d) Conditions of use in horses--(1) Amount. Administer 136 
micrograms (mcg) ivermectin per pound (/lb) body weight (300 mcg/
kilogram) as a single dose on approximately 2 lb grain or sweet feed.
    (2) Indications for use. For treatment and control of Large 
Strongyles (adults): Strongylus vulgaris (also early forms in blood 
vessels), S. edentatus (also tissue stages), S. equinus, 
Triodontophorus spp. including T. brevicauda and T. serratus, and 
Craterostomum acuticaudatum; Small Strongyles (adults, including those 
resistant to some benzimidazole class compounds): Coronocyclus spp. 
including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. 
including C. catinatum and C. pateratum, Cylicocyclus spp. including C. 
insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, 
Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. 
goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; 
Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth 
stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-
stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus 
axei; Large Mouth Stomach Worms (adults): Habronema muscae; Bots (oral 
and gastric stages): Gasterophilus spp. including G. intestinalis and 
G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus 
arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; 
Summer Sores caused by Habronema and Draschia spp. cutaneous third-
stage larvae; Dermatitis caused by neck threadworm microfilariae, 
Onchocerca sp.

[[Page 1818]]

    (3) Limitations. Do not use in horses intended for human consumption.

    Dated: December 29, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-523 Filed 1-10-05; 8:45 am]
BILLING CODE 4160-01-S

 
 

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