Document ID: FDA-2008-N-0039-0095
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Ivermectin Paste - Final Rule
Posted Date: 2009-02-10T05:00Z

[Federal Register: February 10, 2009 (Volume 74, Number 26)]
[Rules and Regulations]
[Page 6541-6542]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10fe09-4]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2008-N-0039]

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

[[Page 6542]]

approval of a supplemental abbreviated new animal drug application
(ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA
provides for use of ivermectin oral paste for the treatment and control
of additional species of gastrointestinal parasites in horses.

DATES: This rule is effective February 10, 2009.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV 104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-286
that provides for oral use of PHOENECTIN (ivermectin) Paste 1.87
percent for the treatment and control of additional species of
gastrointestinal parasites in horses. The supplemental ANADA is
approved as of December 18, 2008, and the regulations are amended in 21
CFR 520.1192 to reflect the approval.
    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 Subject in 21 CFR Part 520

    Animal drugs.

0
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.

0
2. In Sec.  520.1192, remove paragraphs (b)(3), (e)(1)(ii)(A), and
(e)(1)(ii)(B); and revise paragraphs (b)(1), (b)(2), and (e)(1)(ii) to
read as follows:

Sec.  520.1192  Ivermectin paste.

* * * * *
    (b) * * *
    (1) No. 050604 for use of a 1.87 percent paste as in (e)(1) of this
section and a 0.153 percent paste for use as in paragraph (e)(2) of
this section.
    (2) Nos. 051311, 054925, 059130, and 061623 for use of a 1.87
percent paste for use as in paragraph (e)(1) of this section.
* * * * *
    (e) * * *
    (1) * * *
    (ii) 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.
* * * * *

    Dated: February 3, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-2749 Filed 2-9-09; 8:45 am]

BILLING CODE 4160-01-S