Document ID: FDA-2011-N-0003-0004
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Spinosad and Milbemycin Oxime
Posted Date: 2011-03-08T05:00Z

[Federal Register Volume 76, Number 45 (Tuesday, March 8, 2011)]
[Rules and Regulations]
[Pages 12563-12564]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5144]

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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; Spinosad and Milbemycin Oxime

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 Elanco Animal Health. The NADA provides for veterinary 
prescription use of chewable tablets containing spinosad and milbemycin 
oxime in dogs for the treatment and prevention of flea infestations and 
for the prevention and control of various internal parasites.

DATES: This rule is effective March 8, 2011.

FOR FURTHER INFORMATION CONTACT: Angela Clarke, Center for Veterinary 
Medicine (HFV-112), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8318, e-mail: angela.clarke@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 
141-321 that provides for veterinary prescription use of TRIFEXIS 
(spinosad and milbemycin oxime) Chewable Tablets in dogs for the 
treatment and prevention of flea infestations and for the prevention 
and control of various internal parasites. The NADA is approved as of 
January 4, 2011, and the regulations in part 520 (21 CFR part 520) are 
amended by adding Sec.  520.2134 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.
    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.

    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.  520.2134 to read as follows:

Sec.  520.2134  Spinosad and milbemycin.

    (a) Specifications. Each chewable tablet contains 140 milligrams 
(mg) spinosad and 2.3 mg milbemycin oxime, 270 mg spinosad and 4.5 mg 
milbemycin oxime, 560 mg spinosad and 9.3 mg milbemycin oxime, 810 mg 
spinosad and 13.5 mg milbemycin oxime, or 1,620 mg spinosad and 27 mg 
milbemycin oxime.
    (b) Sponsor. See No. 000986 in Sec.  510.600 of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer once a month 
at a

[[Page 12564]]

minimum dosage of 13.5 mg/pound (lb) (30 mg/kilogram (kg)) of body 
weight spinosad and 0.2 mg/lb (0.5 mg/kg) of body weight milbemycin 
oxime.
    (2) Indications for use. To kill fleas; for the prevention and 
treatment of flea infestations (Ctenocephalides felis); for the 
prevention of heartworm disease (Dirofilaria immitis); and for the 
treatment and control of adult hookworm (Ancylostoma caninum), adult 
roundworm (Toxocara canis and Toxascaris leonina), and adult whipworm 
(Trichuris vulpis) infections in dogs and puppies 8 weeks of age or 
older and 5 lbs of body weight or greater.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: March 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5144 Filed 3-7-11; 8:45 am]
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