E6-22542. Oral Dosage Form New Animal Drugs; Dirlotapide

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 Pfizer, Inc. The NADA provides for the veterinary prescription use of dirlotapide solution in dogs for the management of obesity.

DATES:

This rule is effective January 4, 2007.

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, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Pfizer, Inc., 235 East 42d St., New York, NY 10017-5755, filed NADA 141-260 for SLENTROL (dirlotapide) Oral Solution. The NADA provides for the veterinary prescription use of dirlotapide solution in dogs for the management of obesity. The application is approved as of December 12, 2006, and the regulations are amended in 21 CFR part 520 by adding new § 520.666 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 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)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning December 12, 2006.

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 520

• 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 520 is amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 520 continues to read as follows:

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

2. Section 520.666 is added to read as follows:

§ 520.666

Dirlotapide.

(a) Specifications. Each milliliter (mL) of solution contains 5 milligrams (mg) dirlotapide.

(b) Sponsor. See No. 000069 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. The initial dosage is 0.01 mL/kg (0.0045 mL/lb) body weight for the first 14 days. After the first 14 days of treatment, the dose volume is doubled to 0.02 mL/kg (0.009 mL/lb) body weight for the next 14 days (days 15 to 28 of treatment). Dogs should be weighed monthly and the dose volume adjusted every month, as necessary, to maintain a target percent weight loss until the desired weight is achieved.

(2) Indications for use. For the management of obesity.

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

Dated: December 20, 2006.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.