E7-4226. Ophthalmic and Topical Dosage Form New Animal Drugs; Imidacloprid and Moxidectin

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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: [phone]; e-mail: [e-mail].

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 § 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

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

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

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

2. Add § 524.1146 to read as follows:

§ 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 § 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.