Document ID: FDA-2011-N-0003-0011
Agency: fda
Document Type: Rule
Title: Oral Dosages Form New Animal Drugs: Robenacoxib
Posted Date: 2011-04-05T04:00Z

[Federal Register Volume 76, Number 65 (Tuesday, April 5, 2011)]
[Rules and Regulations]
[Page 18648]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8053]

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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; Robenacoxib

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 an original new animal drug 
application (NADA) filed by Novartis Animal Health US, Inc. The NADA 
provides for the veterinary prescription use of robenacoxib tablets in 
cats for the control of postoperative pain and inflammation.

DATES: This rule is effective April 5, 2011.

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, e-mail: amy.omer@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200 
Northline Ave., suite 300, Greensboro, NC 27408, filed NADA 141-320 
that provides for the veterinary prescription use of ONSIOR 
(robenacoxib) Tablets in cats for the control of postoperative pain and 
inflammation associated with orthopedic surgery, ovariohysterectomy, 
and castration. The NADA is approved as of March 8, 2011, and the 
regulations are amended in 21 CFR part 520 by adding Sec.  520.2075 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.
    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.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning on the date of approval.
    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. Add Sec.  520.2075 to read as follows:

Sec.  520.2075  Robenacoxib.

    (a) Specifications. Each tablet contains 6 milligrams (mg) 
robenacoxib.
    (b) Sponsors. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. Administer 0.45 mg per 
pound (/lb) (1 mg/kilogram (kg)) once daily.
    (2) Indications for use. For the control of postoperative pain and 
inflammation associated with orthopedic surgery, ovariohysterectomy, 
and castration in cats weighing at least 5.5 lb (2.5 kg) and at least 6 
months of age; for up to a maximum of 3 days.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: March 31, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-8053 Filed 4-4-11; 8:45 am]
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