[Federal Register Volume 59, Number 126 (Friday, July 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16090]


[[Page Unknown]]

[Federal Register: July 1, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520

 

Oral Dosage Form New Animal Drugs; Praziquantel, Pyrantel 
Pamoate, and Febantel 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 a new animal drug application 
(NADA) filed by Miles, Inc. The NADA provides for the oral use in dogs 
of either of two tablets containing different concentrations of 
praziquantel, pyrantel pamoate, and febantel for the removal of 
tapeworms, hookworms, ascarids, and whipworms.

EFFECTIVE DATE: July 1, 1994.

FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for 
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0614.

SUPPLEMENTARY INFORMATION: Miles, Inc., Agriculture Division, Animal 
Health Products, P.O. Box 390, Shawnee Mission, KS 66201, filed NADA 
141-007 that provides for the oral use in small dogs (up to 11.4 
kilograms (kg) or 25 pounds (lb) of a tablet containing 22.7 milligrams 
(mg) of praziquantel, 22.7 mg of pyrantel (as pyrantel pamoate), and 
113.4 mg of febantel for the removal of certain tapeworms, hookworms, 
ascarids, and whipworms. The NADA also provides for the use in medium 
and large dogs (11.8 kg and or over 26 lb and over) of a tablet 
containing three times the preceding concentrations. The NADA is 
approved as of May 19, 1994, and the regulations are amended in part 
520 (21 CFR part 520) by adding new Sec. 520.1872 to reflect the 
approval. The basis for approval is discussed in the freedom of 
information summary.
    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 for nonfood 
producing animals qualifies for 3 years of marketing exclusivity 
beginning May 19, 1994, because the application contains reports of new 
clinical or field investigations (other than bioequivalence studies) 
essential to the approval of the application and conducted or sponsored 
by the applicant.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets 
Management Branch (HFA-305), Food And Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m. Monday 
through Friday.

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 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. New Sec. 520.1872 is added to read as follows:


Sec. 520.1872  Praziquantel, pyrantel pamoate, and febantel tablets.

    (a) Specifications. Each tablet contains either:
    (1) Tablet No. 1: 22.7 milligrams praziquantel, 22.7 milligrams 
pyrantel base, and 113.4 milligrams febantel; or
    (2) Tablet No. 2: 68 milligrams praziquantel, 68 milligrams 
pyrantel base, and 340.2 milligrams febantel.
    (b)  Sponsor. See 000859 in Sec. 510.600(c) of this chapter.
    (c)  Conditions of use--(1)  Dogs--(i)  Amount. Administer as a 
single dose directly by mouth or in a small amount of food as follows: 

------------------------------------------------------------------------
               Weight of animal                   Number of tablets per 
-----------------------------------------------           dose          
                                               -------------------------
      Kilograms                 Pounds           Tablet no.   Tablet no.
                                                     1            2     
------------------------------------------------------------------------
0.9 to 1.8............  2 to 4................          1/2             
2.3 to 3.2............  5 to 7................            1             
3.6 to 5.4............  8 to 12...............        1 1/2             
5.9 to 8.2............  13 to 18..............            2             
8.6 to 11.4...........  19 to 25..............        2 1/2             
11.8 to 13.6..........  26 to 30..............                         1
14.1 to 20.0..........  31 to 44..............                     1 1/2
20.4 to 27.2..........  45 to 60..............                         2
27.7 to 33.6..........  61 to 74..............                     2 1/2
34.0 to 40.9..........  75 to 90..............                         3
41.3 to 47.2..........  91 to 104.............                     3 1/2
47.7 to 54.5..........  105 to 120............                         4
------------------------------------------------------------------------

    (ii) Indications for use. For the removal of tapeworms (Dipylidium 
caninum, Taenia pisiformis, Echinococcus granulosus); hookworms 
(Ancylostoma caninum, Uncinaria stenocephala); ascarids (Toxocara 
canis, Toxascaris leonina); and whipworms (Trichuris vulpis) in dogs.
    (iii)  Limitations. Do not use in pregnant animals. Do not use in 
dogs weighing less than 0.9 kilogram (2 pounds) or puppies less than 3 
weeks of age. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: June 21, 1994.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 94-16090 Filed 6-30-94; 8:45 am]
BILLING CODE 4160-01-F