[Federal Register Volume 70, Number 34 (Tuesday, February 22, 2005)]
[Rules and Regulations]
[Pages 8513-8514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3280]


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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 Paste

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 an abbreviated new animal drug 
application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA 
provides for oral use of ivermectin paste in horses for treatment and 
control of various internal parasites or parasitic conditions.

DATES: This rule is effective February 22, 2005.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary

[[Page 8514]]

Medicine (HFV-104), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 301-827-8549, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-326 for BIMECTIN 
(ivermectin) Paste 1.87%. The application provides for oral use of 1.87 
percent ivermectin paste in horses for the treatment and control of 
various species of internal parasites or parasitic conditions. Cross 
Vetpharm Group's BIMECTIN Paste 1.87% is approved as a generic copy of 
Merial Limited's EQVALAN Paste, approved under NADA 134-314. ANADA 200-
326 is approved as of January 19, 2005, 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(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.

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:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
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 520.1192 is amended by adding paragraphs (b)(3) and 
(e)(1)(ii)(C) to read as follows:


Sec.  520.1192  Ivermectin paste.

* * * * *
    (b) * * *
    (3) No. 061623 for use of a 1.87 percent paste for use as in 
paragraph (e)(1)(i), (e)(1)(ii)(C), and (e)(1)(iii) of this section.
* * * * *
    (e) * * *
    (1) * * *
    (ii) * * *
* * * * *
    (C) Large strongyles (adults)--Strongylus vulgaris (also early 
forms in blood vessels), S. edentatus (also tissue stages), S. equinus, 
and Triodontophorus spp. including T. brevicauda and T. serratus; Small 
Strongyles (adults, including those resistant to some benzimidazole 
class compounds)--Cyathostomum spp. including C. catinatum and C. 
pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. 
nassatus, and C. brevicapsulatus, Cylicodontophorus spp., and 
Cylicostephanus spp. including C. calicatus, C. goldi, C. 
longibursatus, and C. minutus; 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.
* * * * *

    Dated: February 8, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-3280 Filed 2-18-05; 8:45 am]
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