[Federal Register Volume 67, Number 219 (Wednesday, November 13, 2002)]
[Rules and Regulations]
[Pages 68759-68760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28714]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Deracoxib

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 68760]]

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: 
[email protected].

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 
Sec.  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:


Sec.  520.538  Deracoxib.

    (a) Specifications. Each chewable tablet contains 25 or 100 
milligrams (mg) deracoxib.
    (b) Sponsor. See No. 058198 in Sec.  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.
[FR Doc. 02-28714 Filed 11-12-02; 8:45 am]
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