Document ID: FDA-2011-N-0003-0071
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Milbemycin Oxime, Lufenuron, and Praziquantel
Posted Date: 2012-01-27T05:00Z

[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Rules and Regulations]
[Page 4225]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1744]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]

Oral Dosage Form New Animal Drugs; Milbemycin Oxime, Lufenuron, 
and Praziquantel

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 Novartis Animal Health US, Inc. The NADA provides for 
the veterinary prescription use of milbemycin oxime, lufenuron, and 
praziquantel for the prevention of heartworm disease, for prevention 
and control of fleas, and for the treatment and control of various 
internal parasites in dogs.

DATES: This rule is effective January 27, 2012.

FOR FURTHER INFORMATION CONTACT: Steven Fleischer, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8234, email: 
steven.fleischer@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200 
Northline Ave., Suite 300, Greensboro, NC 27408, filed NADA 141-333 
that provides for the veterinary prescription use of SENTINEL SPECTRUM 
(milbemycin oxime/lufenuron/praziquantel) Tablets for the prevention of 
heartworm disease, for the prevention and control of flea populations, 
and for the treatment and control of adult roundworm, adult hookworm, 
adult whipworm, and adult tapeworm infections in dogs and puppies 2 
pounds of body weight or greater and 6 weeks of age and older. The NADA 
is approved as of December 8, 2011, and 21 CFR part 520 is amended by 
adding new Sec.  520.1447 to reflect the approval.
    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 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 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.  520.1447 to read as follows:

Sec.  520.1447  Milbemycin oxime, lufenuron, and praziquantel tablets.

    (a) Specifications. Each tablet contains:
    (1) 2.3 milligrams (mg) milbemycin oxime, 46 mg lufenuron, and 22.8 
mg praziquantel;
    (2) 5.75 mg milbemycin oxime, 115 mg lufenuron, and 57 mg 
praziquantel;
    (3) 11.5 mg milbemycin oxime, 230 mg lufenuron, and 114 mg 
praziquantel; or
    (4) 23 mg milbemycin oxime, 460 mg lufenuron, and 228 mg 
praziquantel.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 0.5 mg milbemycin 
oxime, 10 mg lufenuron, and 5 mg of praziquantel per kilogram of body 
weight, once a month.
    (ii) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis; for the prevention and control of flea 
populations (Ctenocephalides felis); and for the treatment and control 
of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm 
(Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult 
tapeworm (Taenia pisiformis, Echinococcus multilocularis, and E. 
granulosus) infections in dogs and puppies 2 pounds of body weight or 
greater and 6 weeks of age and older.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

    Dated: January 23, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-1744 Filed 1-26-12; 8:45 am]
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