Document ID: FDA-2010-N-0002-0041
Agency: fda
Document Type: Rule
Title: Ophthalmic and Topical Dosage Form New Animal Drugs: Ivermectin Topical Solution
Posted Date: 2010-05-12T04:00Z

[Federal Register: May 12, 2010 (Volume 75, Number 91)]
[Rules and Regulations]               
[Page 26647-26648]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my10-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

[Docket No. FDA-2010-N-0002]

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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule, technical amendment.

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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 First Priority, Inc. 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 May 12, 2010.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: First Priority, Inc., 1590 Todd Farm Dr., 
Elgin, IL 60123, filed a supplement to ANADA 200-340 for PRIVERMECTIN 
(ivermectin), a topical solution used on cattle to control infestations 
of certain species of external and internal parasites. The supplemental 
ANADA

[[Page 26648]]

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 March 26, 2010, and 21 
CFR 524.1193 is amended to reflect the approval.
    In addition, FDA has noticed the regulations do not accurately 
reflect approved indications for generic products. At this time, the 
regulations are being revised to reflect which generic products have 
approved labeling for the durations of persistent effectiveness 
approved for the pioneer product. FDA is also adding a parasite species 
that was inadvertently omitted in the previously cited January 6, 2004, 
final rule. These actions are being taken to improve the accuracy of 
the regulations.
    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 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 524

    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 524 is 
amended as follows:

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

0
1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

0
2. In Sec.  524.1193, revise paragraphs (b) and (e)(2) to read as 
follows:

Sec.  524.1193  Ivermectin topical solution.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) Nos. 050604, 055529, 058829 for use as in paragraphs (e)(1), 
(e)(2)(i), (e)(2)(iii), and (e)(3) of this section.
    (2) Nos. 054925, 059130, 061623, and 066916 for use as in 
paragraphs (e)(1), (e)(2)(i), (e)(2)(ii), and (e)(3) of this section.
* * * * *
    (e) * * *
    (2) Indications for use--(i) It is used 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.
    (ii) It controls infections and prevents reinfection with O. 
ostertagi, O. radiatum, H. placei, T. axei, C. punctata, and C. 
oncophora for 14 days after treatment.
    (iii) 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, O. ostertagi, H. placei, C. 
oncophora, and C. surnabada for 14 days after treatment, and D. bovis 
for 56 days after treatment.
* * * * *

    Dated: May 6, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-11244 Filed 5-11-10; 8:45 am]
BILLING CODE 4160-01-S