01-17049. Implantation or Injectable Dosage Form New Animal Drugs; 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 a new animal drug application (NADA) filed by Fort Dodge Animal Health. The NADA provides for veterinary prescription use of a sustained-release injectable moxidectin formulation for prevention of heartworm disease and treatment of existing hookworm infections in dogs.

DATES:

This rule is effective July 9, 2001.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7540.

SUPPLEMENTARY INFORMATION:

Fort Dodge Animal Health, Div. of American Home Products Corp., 800 Fifth St. NW., Fort Dodge, IA 50501, filed NADA 141-189 that provides for veterinary prescription use of ProHeart® 6 (moxidectin) Sustained Release Injectable for Dogs for prevention of heartworm disease caused by Dirofilaria immitis and treatment of existing larval and adult hookworm (Ancylostoma caninum) infections. The NADA is approved as of June 6, 2001, and the regulations are amended in 21 CFR part 522 by adding new § 522.1451 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 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 Dockets Management Branch (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 for nonfood-producing animals qualifies for 3 years of marketing exclusivity beginning June 6, 2001, because the application contains substantial evidence of effectiveness of the drug involved or any studies of animal safety required for approval of the application and conducted or sponsored by the applicant.

The agency has determined under 21 CFR 25.33(d)(1) 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 522

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 522 is amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 522 continues to read as follows:

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

2. Section 522.1451 is added to read as follows:

§ 522.1451

Moxidectin.

(a) Specifications. The drug product consists of two separate vials. One contains 10 percent moxidectin microspheres, and the other contains a vehicle for constitution of the moxidectin microspheres. Each milliliter of constituted, sustained-release suspension contains 3.4 milligrams (mg) of moxidectin.

(b) Sponsor. See No. 000856 in § 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use; dogs—(1) Amount. 0.17 mg per kilogram body weight (0.0773 mg per pound) as a single subcutaneous injection.

(2) Indications for use. For prevention of heartworm disease caused by Dirofilaria immitis; for treatment of existing larval and adult hookworm (Ancylostoma caninum) infections.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: June 25, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.