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Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin

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Information about this document as published in the Federal Register.

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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 an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for use of a one percent ivermectin solution by subcutaneous injection in cattle, swine, reindeer, and American bison for the treatment and control of various internal and external parasites.

DATES:

This rule is effective May 17, 2007.

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FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: john.harshman@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland, filed supplemental ANADA 200-437 that provides for use of NOROMECTIN (ivermectin) Injection for Cattle and Swine by subcutaneous injection in cattle, swine, reindeer, and American bison for the treatment and control of various internal and external parasites. Norbrook Laboratories, Ltd.'s NOROMECTIN Injection for Cattle and Swine is approved as a generic copy of Merial, Ltd.'s IVOMEC Injection for Cattle and Swine approved under NADA 128-409. The ANADA is approved as of April 20, 2007, and the regulations are amended in 21 CFR 522.1192 to reflect the approval and a current format.

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.

FDA has determined under 21 CFR 25.33(a)(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.

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List of Subjects in 21 CFR Part 522

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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,

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PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for

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

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2. Revise § 522.1192 to read as follows:

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Ivermectin.

(a) Specifications—(1) Each milliliter (mL) of solution contains 20 milligrams (mg) ivermectin.

(2) Each mL of solution contains 10 mg ivermectin.

(3) Each mL of solution contains 2.7 mg ivermectin.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) No. 050604 for use of the product described in paragraph (a)(1) of this section as in paragraph (e)(1) of this section; the product described in paragraph (a)(2) of this section as in paragraphs (e)(2)(i), (e)(2)(ii)(A), (e)(2)(ii)(C), (e)(2)(iii), (e)(3), (e)(4) and (e)(5) of this section; and the product described in paragraph (a)(3) of this section as in paragraphs (e)(3) and (e)(6) of this section.

(2) Nos. 059130 and 055529 for use of the product described in paragraph (a)(2) of this section as in paragraphs (e)(2)(i), (e)(2)(ii)(A), (e)(2)(ii)(B), (e)(2)(iii), (e)(3), (e)(4), and (e)(5) of this section.

(c) Related tolerances. See § 556.344 of this chapter.

(d) Special considerations—(1) See § 500.25 of this chapter.

(2) Labeling shall bear the following precaution: “This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.”

(e) Conditions of use—(1) Horses—(i) Amount. 200 micrograms per kilogram (µg/kg) of body weight by intramuscular injection.

(ii) Indications for use. For the treatment and control of large strongyles (adult) (Strongylus vulgaris, S. edentatus, Triodontophorus spp.), small strongyles (adult and fourth stage larvae) (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp.), pinworms (adult and fourth-stage larvae) (Oxyuris equi), large roundworms (adult) (Parascaris equorum), hairworms (adult) (Trichostrongylus axei), large mouth stomach worms (adult) (Habronema muscae), neck threadworms (microfilariae) (Onchocerca spp.), and stomach bots (Gastrophilus spp.).

(iii) Limitations. Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cattle—(i) Amount. 200 µg/kg of body weight by subcutaneous injection.

(ii) Indications for use—(A) For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, T. axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum); lungworms (adults and fourth-stage larvae) (Dictyocaulus viviparus); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (scabies) (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis).

(B) For control of infections of D. viviparus for 28 days after treatment, and O. ostertagi for 21 days after treatment, and H. placei, T. axei, C. punctata, C. oncophora, and O. radiatum for 14 days after treatment.

(C) For control of infections and to protect from reinfection with D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, T. axei, and C. punctata for 21 days after treatment; H. placei and C. oncophora for 14 days after treatment.

(iii) Limitations. Do not treat cattle within 35 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

(3) Swine—(i) Amount. 300 µg/kg of body weight by subcutaneous injection.

(ii) Indications for use. For the treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (large roundworm, Ascaris suum; red stomach worm, Hyostrongylus rubidus; nodular worm, Oesophagostomum spp.; threadworm, Strongyloides ransomi (adults only)); somatic roundworm larvae (threadworm, S. ransomi (somatic larvae)); lungworms (Metastrongylus spp. (adults only)); lice (H. suis); and mites (S. scabiei var. suis).

(iii) Limitations. Do not treat swine within 18 days of slaughter.

(4) American bison—(i) Amount. 200 µg/kg of body weight by subcutaneous injection.

(ii) Indications for use. For the treatment and control of grubs (H. bovis).

(iii) Limitations. Do not slaughter within 56 days of last treatment.

(5) Reindeer—(i) Amount. 200 µg/kg of body weight by subcutaneous injection.

(ii) Indications for use. For the treatment and control of warbles (Oedemagena tarandi).

(iii) Limitations. Do not treat reindeer within 56 days of slaughter.

(6) Ranch-raised foxes—(i) Amount. 200 µg/kg of body weight by subcutaneous injection. Repeat in 3 weeks.

(ii) Indications for use. For treatment and control of ear mites (Otodectes cynotis).

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Dated: May 7, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.

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[FR Doc. E7-9515 Filed 5-16-07; 8:45 am]

BILLING CODE 4160-01-S