[Federal Register Volume 69, Number 185 (Friday, September 24, 2004)]
[Rules and Regulations]
[Pages 57173-57174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21415]


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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 Liquid

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 Merial Ltd. The supplemental NADA provides 
revised labeling, including the addition of four new species of 
internal parasites, for ivermectin oral liquid used in horses.

DATES: This rule is effective September 24, 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: 
[email protected].

SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640, filed a supplement to NADA 140-439 for 
EQVALAN (ivermectin) Oral Liquid for Horses. The supplemental 
application provides for revisions to the labeled indications. 
Specifically, the supplement provides for the use of ivermectin oral 
liquid for the treatment and control of Craterostomum acuticaudatum, 
Petrovinema poculatum, and Coronocyclus spp., including Coronocyclus 
coronatus and Coronocyclus labratus. The label descriptions of some 
currently approved parasite genera are also being revised to add 
included species for which data already exists in the NADA file and to 
reflect changes in scientific nomenclature. In addition, 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 520.1195 
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, Room 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 supplemental approval 
qualifies for 3 years of marketing exclusivity beginning August 9, 
2004. This marketing exclusivity only applies to the parasites 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.

    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 520.1195 is amended by revising paragraphs (b), 
(e)(1)(ii), and (e)(1)(iii) to read as follows:


Sec.  520.1195  Ivermectin liquid.

* * * * *
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) No. 050604 for use of product described in paragraph (a)(1) of 
this section as in paragraph (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) 
of this section.
    (2) Nos. 051259, 058829, and 059130 for use of product described in 
paragraph (a)(1) of this section as in paragraph (e)(1)(i), 
(e)(1)(ii)(B), and (e)(1)(iii) of this section.
    (3) Nos. 050604 and 058829 for use of product described in 
paragraph (a)(2) of this section as in paragraph (e)(2) of this 
section.
* * * * *
    (e) * * *
    (1) * * *
    (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 (Strongylus equinus (adult), S. vulgaris 
(adult and arterial larval stages), S. endentatus (adult and migrating 
tissue stages), Triodontophorus spp. (adult)); Small Strongyles 
including those resistant to some benzimidazole class compounds 
(Cyathostomum spp. (adult and fourth-stage larvae), Cylicocyclus spp., 
Cylicodontophorus spp., Cylicostephanus spp.); Pinworms (Oxyuris equi 
(adult and fourth-stage larvae)); Ascarids (Parascaris equorum (adult 
and third- and fourth-stage larvae)); Hairworms (Trichostongylus

[[Page 57174]]

axei(adult)); Large mouth Stomach Worms (Habronema muscae (adult)); 
Stomach Bots (Gastrophilus spp. (oral and gastric stages)); Lungworms 
(Dictyocaulus arnfieldi (adult and fourth-stage larvae)); intestinal 
threadworms (Strongyloides westeri (adult)); Summer Sores caused by 
Habronema and Draschia spp. cutaneous third-stage larvae; and 
Dermatitis caused by neck threadworm microfilariae (Onchocerca spp.).
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
* * * * *

    Dated: September 14, 2004.
Daniel G. McChesney,
Director, Office of Surveillance and Compliance, Center for Veterinary 
Medicine.
[FR Doc. 04-21415 Filed 9-23-04; 8:45 am]
BILLING CODE 4160-01-S