03-9532. 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 supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for the veterinary prescription use of deracoxib tablets in dogs for the control of pain and inflammation associated with osteoarthritis.

DATES:

This rule is effective April 17, 2003.

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 a supplement to NADA 141-203 that provides for the veterinary prescription use of DERAMAXX (deracoxib) Chewable Tablets for the control of pain and inflammation associated with osteoarthritis. The supplemental NADA is approved as of February 11, 2003, and 21 CFR 520.538 is amended 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 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)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning February 11, 2003.

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 amended by revising paragraphs (d)(1) and (d)(2) to read as follows:

§ 520.538

Deracoxib.

* * * * *

(d) * * * (1) Amount. Administer orally as needed, as a single daily dose based on body weight.

(i) 1 to 2 mg/kilograms (kg) (0.45 to 0.91 mg/pound (lb), for use as in paragraph (d)(2)(i) of this section.

(ii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as in paragraph (d)(2)(ii) of this section.

(2) Indications for use. (i) For the control of pain and inflammation associated with osteoarthritis.

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

* * * * *

Dated: March 8, 2003.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.