Oral Dosage Form New Animal Drugs; Ivermectin, Pyrantel, and Praziquantel Tablets, 65052 [E6-18684]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 215 (Tuesday, November 7, 2006)]
[Rules and Regulations]
[Page 65052]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18684]


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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, Pyrantel, and 
Praziquantel 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 original new animal drug 
application (NADA) filed by Virbac AH, Inc. The NADA provides for 
veterinary prescription use of chewable tablets in dogs containing 
ivermectin, pyrantel pamoate, and praziquantel for the treatment and 
control or prevention of various internal parasites.

DATES:  This rule is effective November 7, 2006.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. 
Worth, TX 76137, filed NADA 141-257 for IVERHART MAX (ivermectin, 
pyrantel pamoate, praziquantel) Chewable Tablets that provides for 
veterinary prescription use of chewable tablets in dogs containing 
ivermectin, pyrantel pamoate, and praziquantel for the treatment and 
control or prevention of various internal parasites. The NADA is 
approved as of October 13, 2006, and 21 CFR part 520 is amended by 
adding new Sec.  520.1199 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 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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(ii)), this approval 
qualifies for 3 years of marketing exclusivity beginning October 13, 
2006.
    FDA 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 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. Add Sec.  520.1199 to read as follows:


Sec.  520.1199  Ivermectin, pyrantel, and praziquantel tablets.

    (a) Specifications. Each chewable tablet contains:
    (1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel 
pamoate, and 28.5 mg praziquantel;
    (2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg 
praziquantel;
    (3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg 
praziquantel; or
    (4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg 
praziquantel.
    (b) Sponsors. See No. 051311 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer monthly 
according to body weight as follows:
    (i) 6 to 12 lb: one tablet as described in paragraph (a)(1) of this 
section.
    (ii) 12.1 to 25 lb: one tablet as described in paragraph (a)(2) of 
this section.
    (iii) 25.1 to 50 lb: one tablet as described in paragraph (a)(3) of 
this section.
    (iv) 50.1 to 100 lb: one tablet as described in paragraph (a)(4) of 
this section.
    (v) Greater than 100 lb: use the appropriate combination of 
tablets.
    (2) Indications for use. Prevents canine heartworm disease by 
eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) 
for 1 month (30 days) after infection and for the treatment and control 
of roundworm (Toxocara canis, Toxascaris leonina), hookworm 
(Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) 
and tapeworm (Dipylidium caninum, Taenia pisiformis) infections.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: October 23, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-18684 Filed 11-6-06; 8:45 am]
BILLING CODE 4160-01-S