02-28714. Oral Dosage Form New Animal Drugs; Deracoxib

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 Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription use of deracoxib tablets for the control of postoperative pain and inflammation associated with orthopedic surgery in dogs.

DATES:

This rule is effective November 13, 2002.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408, filed NADA 141-203 that provides for the veterinary prescription use of DERAMAXX (deracoxib) Chewable Tablets for the control of postoperative pain and inflammation associated with orthopedic surgery in dogs weighing four or more pounds (1.8 kilograms). The NADA is approved as of August 21, 2002 , and the regulations are amended in 21 CFR part 520 by adding new § 520.538 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)(i) of the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning August 21, 2002.

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 520.538 is added to read as follows:

§ 520.538

Deracoxib.

(a) Specifications. Each chewable tablet contains 25 or 100 milligrams (mg) deracoxib.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use in dogs—(1) Amount. 3 to 4 mg per kilogram (kg) (1.4 to 1.8 mg per pound) of body weight once daily for 7 days, given orally.

(2) Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery in dogs weighing 4 or more pounds (1.8 kg).

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

Dated: October 25, 2002.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.