Document ID: FDA-2008-N-0039-0053
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Ivermectin, Fenbendazole, and Praziquantel Tablets
Posted Date: 2008-06-13T04:00Z

[Federal Register: June 13, 2008 (Volume 73, Number 115)]
[Rules and Regulations]               
[Page 33692]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn08-12]                         

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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, Fenbendazole, 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 Intervet, Inc. The NADA provides for the 
veterinary prescription use of chewable tablets containing ivermectin, 
fenbendazole, and praziquantel for the treatment and control of various 
internal parasites and for the prevention of canine heartworm disease 
in adult dogs.

DATES: This rule is effective June 13, 2008.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet 
Lane, Millsboro, DE 19966, filed NADA 141-286 that provides for the 
veterinary prescription use of PANACUR Plus (ivermectin, fenbendazole, 
and praziquantel) Soft Chews for the treatment and control of various 
internal parasites and for the prevention of canine heartworm disease 
in adult dogs. The NADA is approved as of May 9, 2008, and the 
regulations are amended in 21 CFR part 520 by adding Sec.  520.1200 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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning on the date of approval.
    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.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
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.  520.1200 to read as follows:

Sec.  520.1200  Ivermectin, fenbendazole, and praziquantel tablets.

    (a) Specifications. Each chewable tablet contains either:
    (1) 68 micrograms ([micro]g) ivermectin, 1.134 grams fenbendazole, 
and 57 milligrams (mg) praziquantel; or
    (2) 27 [micro]g ivermectin, 454 mg fenbendazole, and 23 mg 
praziquantel.
    (b) Sponsor. See No. 057926 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer tablets to 
provide 6 [micro]g per kilogram (/kg) ivermectin, 100 mg/kg 
fenbendazole, and 5 mg/kg praziquantel.
    (2) Indications for use. For the treatment and control of adult 
Toxocara canis (roundworm), Ancylostoma caninum (hookworm), Trichuris 
vulpis (whipworm), and Dipylidium caninum (tapeworm), and for the 
prevention of heartworm disease caused by Dirofilaria immitis in adult 
dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: June 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-13354 Filed 6-12-08; 8:45 am]

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