[Federal Register Volume 66, Number 131 (Monday, July 9, 2001)]
[Rules and Regulations]
[Pages 35755-35756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17051]


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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 and Pyrantel 
Pamoate Chewable Tablets

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 Blue Ridge Pharmaceuticals, Inc. The ANADA 
provides for use of chewable tablets containing ivermectin and pyrantel 
pamoate for prevention of heartworm disease and for treatment and 
control of certain gastrointestinal parasites in dogs.

DATES: This rule is effective July 9, 2001.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Blue Ridge Pharmaceuticals, Inc., 4249-105 
Piedmont Pkwy., Greensboro, NC 27410, filed ANADA 200-302 that provides 
for veterinary prescription use of IverhartTM Plus 
(ivermectin and pyrantel pamoate) Flavored Chewables for Dogs for 
prevention of canine heartworm disease caused by Dirofilaria immitis 
and for treatment and control of ascarids (Toxocara canis, T. leonina) 
and hookworms (Ancylostoma caninum, A. braziliense, and Uncinaria 
stenocephala) in dogs. Blue Ridge's IverhartTM Plus Flavored 
Chewables for Dogs is approved as a generic copy of Merial's Heartgart 
TM Plus Chewables, approved under NADA 140-971. ANADA 200-
302 is approved as of May 30, 2001, and 21 CFR 520.1196 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 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 Dockets Management Branch (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(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

[[Page 35756]]

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.


Sec. 520.1196  [Amended]

    2. Section 520.1196 Ivermectin and pyrantel pamoate chewable tablet 
is amended in paragraph (b) by removing ``Sponsor. See 050604'' and by 
adding in its place ``Sponsors. See Nos. 050604 and 065274''.

    Dated: June 20, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-17051 Filed 7-6-01; 8:45 am]
BILLING CODE 4160-01-S