[Federal Register Volume 68, Number 74 (Thursday, April 17, 2003)]
[Rules and Regulations]
[Pages 18882-18883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9532]


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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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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: 
[email protected].

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.

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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

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

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

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2. Section 520.538 is amended by revising paragraphs (d)(1) and (d)(2) 
to read as follows:


Sec.  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.

[[Page 18883]]

    (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.
[FR Doc. 03-9532 Filed 4-16-03; 8:45 am]
BILLING CODE 4160-01-S