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Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: February 12, 2007 (Volume 72, Number 28)]
[Rules and Regulations]
[Page 6463-6464]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12fe07-9]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524

Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin
Topical Solution

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 abbreviated new
animal drug application (ANADA) filed by Norbrook Laboratories, Ltd.
The supplemental ANADA adds claims for persistent effectiveness against
various species of external and internal parasites when cattle are
treated with a topical solution of ivermectin.

DATES:  This rule is effective February 12, 2007.

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.

SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed a supplement to ANADA 200-272
for Ivermectin Pour-On for Cattle. The supplemental ANADA adds claims
for persistent effectiveness against various species of external and
internal parasites that were approved for the pioneer product with 3
years of marketing exclusivity (69 FR 501, January 6, 2004). The
supplemental ANADA is approved as of January 19, 2007, and 21 CFR
524.1193 is amended 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.
    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.

[[Page 6464]]

    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 congressional review requirements in 5
U.S.C. 801-808.

List of Subjects in 21 CFR Part 524

    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 524 is
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

? 1. The authority citation for 21 CFR part 524 continues to read as
follows:

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

? 2. In Sec.  524.1193, revise the section heading, and paragraphs (b)
and (e)(2) to read as follows:

Sec.  524.1193   Ivermectin topical solution.

* * * * *
    (b) Sponsors. See Nos. 050604, 051311, 054925, 055529, 058829,
059130, and 066916 in Sec.  510.600(c) of this chapter for use as in
paragraph (e) of this section.
* * * * *
    (e) * * *
    (2) Indications for use in cattle. For the treatment and control
of: Gastrointestinal roundworms (adults and fourth-stage larvae)
Ostertagia ostertagi (including inhibited stage), Haemonchus placei,
Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C.
punctata, C. surnabada, Oesophagostomum radiatum; (adults)
Strongyloides papillosus, Trichuris spp.; lungworms (adults and fourth-
stage larvae) Dictyocaulus viviparus; cattle grubs (parasitic stages)
Hypoderma bovis, H. lineatum; mites Sarcoptes scabiei var. bovis; lice
Linognathus vituli, Haematopinus eurysternus, Damalinia bovis,
Solenoptes capillatus; and horn flies Haematobia irritans. It controls
infections and prevents reinfection with O. radiatum and D. viviparus
for 28 days after treatment, C. punctata and T. axei for 21 days after
treatment, H. placei, C. oncophora, and C. surnabada for 14 days after
treatment, and D. bovis for 56 days after treatment.
* * * * *

    Dated: February 2, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E7-2368 Filed 2-9-07; 8:45 am]
BILLING CODE 4160-01-S

 
 

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