Document ID: FDA-2011-N-0003-0060
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Deracoxib
Posted Date: 2012-01-26T05:00Z

[Federal Register Volume 77, Number 17 (Thursday, January 26, 2012)]
[Rules and Regulations]
[Pages 3927-3928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1622]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]

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 U.S., Inc. The 
supplemental NADA provides for veterinary prescription use of deracoxib 
tablets in dogs for the control of postoperative pain and inflammation 
associated with dental surgery and the addition of a 12-milligram (mg) 
size tablet.

DATES: This rule is effective January 26, 2012.

FOR FURTHER INFORMATION CONTACT: Amy L. Omer, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8336, email: amy.omer@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Novartis Animal Health U.S., Inc., 3200 
Northline Ave., Suite 300, Greensboro, NC 27408, filed a supplement to 
NADA 141-203 that provides for veterinary prescription use of DERAMAXX 
(deracoxib) Chewable Tablets in dogs for the control of postoperative 
pain and inflammation associated with dental surgery and the addition 
of a 12-mg size tablet. The supplemental NADA is

[[Page 3928]]

approved as of November 23, 2011, and 21 CFR 520.538 is amended to 
reflect the approval.
    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.
    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 on the date of 
approval.
    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.

    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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. In Sec.  520.538, revise paragraphs (a), (d)(1), and (d)(2) to read 
as follows:

Sec.  520.538  Deracoxib.

    (a) Specifications. Each tablet contains 12, 25, 50, 75, or 100 
milligrams (mg) deracoxib.
* * * * *
    (d) * * *
    (1) Amount. Administer orally as needed, as a single daily dose 
based on body weight:
    (i) 1 to 2 mg/kilogram (kg) (0.45 to 0.91 mg/pound (lb)), for use 
as in paragraph (d)(2)(i) of this section.
    (ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for 3 days, for use as in 
paragraph (d)(2)(ii) of this section.
    (iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as 
in paragraph (d)(2)(iii) 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 dental surgery.
    (iii) For the control of postoperative pain and inflammation 
associated with orthopedic surgery.
* * * * *

    Dated: January 23, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-1622 Filed 1-25-12; 8:45 am]
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