04-22182. Oral Dosage Form New Animal Drugs; Ivermectin Paste

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 supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides revised labeling for ivermectin oral paste used in horses.

DATES:

This rule is effective October 4, 2004.

FOR FURTHER INFORMATION CONTACT:

Martine Hartogensis, Center for Veterinary Medicine (HFV-216), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-7815, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640, filed a supplement to NADA 134-314 for EQVALAN (ivermectin 1.87 percent) Paste for Horses. The supplemental application provides for revisions to the labeled indications. Specifically, under the sub-heading “Small Strongyles,” the labeling has been revised to separate the listing of adult species from the fourth-stage larvae. The supplemental NADA is approved as of August 9, 2004, and 21 CFR 520.1192 is amended 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.

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 520.1192 is amended by revising paragraph (e)(1) to read as follows:

§ 520.1192

Ivermectin paste.

(e) Conditions of use—(1) Horses—(i) Amount. 200 micrograms per kilogram (91 micrograms per pound) of body weight.

(ii) Indications for use. For treatment and control of:

(A) 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.

(B) Large Strongyles (adult) (Strongylus equinus), (adult and arterial larval stages) (Strongylus vulgaris), (adult and migrating tissue stages) (Strongylus edentatus), (adult) (Triodontophorus spp.); Small Strongyles, including those resistant to some benzimidazole class compounds (adult and fourth-stage larvae) (Cyathostomum spp., Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp.); Pinworms (adult and fourth-stage larvae) (Oxyuris equi); Ascarids (third- and fourth-stage larvae and adults) (Parascaris equorum); hairworms (adult) (Trichostrongylus axei); Large mouth Stomach Worms (adult) (Habronema muscae); Stomach Bots (oral and gastric stages) (Gastrophilus spp.); 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; and Dermatitis caused by neck threadworm microfilariae (Onchocerca sp.).

(iii) Limitations. For oral use only. Do not use in horses intended for human consumption.

Dated: September 14, 2004.

Daniel G. McChesney,

Director, Office of Surveillance and Compliance, Center for Veterinary Medicine.