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Rule

Oral Dosage Form New Animal Drugs; Robenacoxib

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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.

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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.

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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 § 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.

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List of Subjects in 21 CFR Part 520

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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:

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PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for

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

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2. Add § 520.2075 to read as follows:

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Robenacoxib.

(a) Specifications. Each tablet contains 6 milligrams (mg) robenacoxib.

(b) Sponsors. See No. 058198 in § 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.

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Dated: March 31, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. 2011-8053 Filed 4-4-11; 8:45 am]

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