Document ID: FDA-2008-N-0039-0051
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Deracoxib
Posted Date: 2008-06-13T04:00Z

[Federal Register: June 13, 2008 (Volume 73, Number 115)]
[Rules and Regulations]               
[Page 33691-33692]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn08-11]                         

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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 addition of a 50-milligram size 
deracoxib tablet which is used for the control of pain and inflammation 
in dogs.

DATES: This rule is effective June 13, 2008.

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: 
melanie.berson@fda.hhs.gov.

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 addition of a 50-milligram size of 
DERAMAXX (deracoxib) Chewable Tablets, used for the control of pain and 
inflammation in dogs. The supplemental NADA is approved as of May 16, 
2008, and 21 CFR 520.538 is amended to reflect the approval.
    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.
    The agency has determined under 21 CFR 25.33 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.

[[Page 33692]]

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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.

Sec.  520.538  [Amended]

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2. In paragraph (a) of Sec.  520.538, remove ``25, 75, or 100 
milligrams'' and in its place add ``25, 50, 75, or 100 milligrams''.

    Dated: June 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-13353 Filed 6-12-08; 8:45 am]

BILLING CODE 4160-01-S