Document ID: FDA-2010-N-0002-0039
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs: Ivermectin
Posted Date: 2010-05-12T04:00Z

[Federal Register: May 12, 2010 (Volume 75, Number 91)]
[Rules and Regulations]               
[Page 26647]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my10-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

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

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Ivermectin

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 Sparhawk Laboratories, Inc. The ANADA 
provides for use of an ivermectin injectable solution in cattle and 
swine for treatment and control of various internal and external 
parasites.

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: Sparhawk Laboratories, Inc., 12340 Santa Fe 
Trail Dr., Lenexa, KS 66215, filed ANADA 200-429 for the use of 
Ivermectin Injection in cattle and swine for treatment and control of 
various internal and external parasites. Sparhawk Laboratories, Inc.'s, 
Ivermectin Injection is approved as a generic copy of Merial Ltd.'s 
IVOMEC Injection for Cattle and Swine, approved under NADA 128-409. The 
ANADA is approved as of March 26, 2010, and the regulations in 21 CFR 
522.1192 are 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.
    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 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. In Sec.  522.1192, revise paragraphs (b)(1), (b)(2), and (e)(2)(ii) 
to read as follows:

Sec.  522.1192.  Ivermectin

* * * * *
    (b)* * *
    (1) No. 050604 for use of the product described in paragraph (a)(1) 
of this section as in paragraph (e)(1) of this section; the product 
described in paragraph (a)(2) of this section as in paragraphs (e)(2), 
(e)(3), (e)(4), and (e)(5) of this section; and the product described 
in paragraph (a)(3) of this section as in paragraphs (e)(3) and (e)(6) 
of this section.
    (2) Nos. 055529, 058005, and 059130 for use of the product 
described in paragraph (a)(2) of this section as in paragraphs (e)(2), 
(e)(3), (e)(4), and (e)(5) of this section.
* * * * *
    (e) * * *
    (2) * * *
    (ii) Indications for use. For the treatment and control of 
gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus 
placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, 
Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. 
punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus 
helvetianus (adults only), N. spathiger (adults only), Bunostomum 
phlebotomum); lungworms (adults and fourth-stage larvae) (Dictyocaulus 
viviparus); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); 
sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes 
capillatus); mites (scabies) (Psoroptes ovis (syn. P. communis var. 
bovis), Sarcoptes scabiei var. bovis). For control of infections and to 
protect from reinfection with D. viviparus and O. radiatum for 28 days 
after treatment; O. ostertagi, T. axei, and C. punctata for 21 days 
after treatment; H. placei and C. oncophora for 14 days after 
treatment.
* * * * *

    Dated: May 7, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-11282 Filed 5-11-10; 8:45 am]
BILLING CODE 4160-01-S