[Federal Register Volume 76, Number 45 (Tuesday, March 8, 2011)]
[Rules and Regulations]
[Pages 12563-12564]
From the Federal Register Online via the Government Publishing 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: [email protected].
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]
BILLING CODE 4160-01-P