[Federal Register Volume 72, Number 46 (Friday, March 9, 2007)]
[Rules and Regulations]
[Pages 10597-10598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Imidacloprid 
and Moxidectin

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 two new animal drug 
applications (NADAs) filed by Bayer HealthCare LLC. The NADAs provide 
for the topical use by veterinary prescription of topical solutions 
containing imidacloprid and two strengths of moxidectin, one for use on 
dogs and the other for use on cats, for the prevention of heartworm 
disease, the treatment of flea infestations, and the treatment and 
control of several internal parasites.

DATES: This rule is effective March 9, 2007.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855; tel: 301-827-7540; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Bayer HealthCare LLC, Animal Health 
Division, P.O. Box 390, Shawnee Mission, KS 66201, filed NADA 141-251 
that provides for veterinary prescription use of ADVANTAGE MULTI 
(imidacloprid 10% and moxidectin 2.5%) for Dogs, a topical solution 
used for the prevention of heartworm disease, the treatment of flea 
infestations, and the treatment and control of several internal 
parasites. Bayer HealthCare LLC also filed NADA 141-254 that provides 
for veterinary prescription use of ADVANTAGE MULTI (imidacloprid 10% 
and moxidectin 1%) for Cats, a topical solution used for the prevention 
of heartworm disease, the treatment of flea infestations, and the 
treatment and control of ear mites and several internal parasites. NADA 
141-251 is approved as of December 20, 2006, and NADA 141-254 is 
approved as of January 19, 2007. Accordingly, the regulations are 
amended in part 524 (21 CFR part 524) by adding Sec.  524.1146 to 
reflect these approvals.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and 
effectiveness data and information submitted to support approval of 
these applications 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 under NADA 
141-251 qualifies for 3 years of marketing exclusivity beginning 
December 20, 2006, and this approval under NADA 141-254 qualifies for 3 
years of marketing exclusivity beginning January 19, 2007.
    The agency has determined under 21 CFR 25.33(d)(1) that these 
actions are of a type that do 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 524

    Animal drugs.

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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 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. Add Sec.  524.1146 to read as follows:

[[Page 10598]]

Sec.  524.1146  Imidacloprid and moxidectin.

    (a) Specifications--(1) Each milliliter of solution contains 100 
milligrams (mg) imidacloprid and 25 mg moxidectin for use as in 
paragraph (d)(1) of this section.
    (2) Each milliliter of solution contains 100 mg imidacloprid and 10 
mg moxidectin for use as in paragraph (d)(2) of this section.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount. Topically apply 4.5 
mg/lb body weight (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) 
moxidectin, once a month.
    (ii) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis; and the treatment and control of 
intestinal roundworms (Toxocara canis and Toxascaris leonina), 
hookworms (Ancylostoma caninum and Uncinaria stenocephala), and 
whipworms (Trichuris vulpis); kills adult fleas and treats flea 
infestations (Ctenocephalides felis).
    (2) Cats--(i) Amount. Topically apply 4.5 mg/lb body weight (10 mg/
kg) imidacloprid and 0.45 mg/lb (1.0 mg/kg) moxidectin, once a month.
    (ii) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis; for the treatment and control of ear 
mite (Otodectes cynotis) infestations, intestinal roundworms (Toxocara 
cati), and hookworms (Ancylostoma tubaeforme); kills adult fleas and 
treats flea infestations (Ctenocephalides felis).

    Dated: February 27, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-4226 Filed 3-8-07; 8:45 am]
BILLING CODE 4160-01-S