Oral Dosage Form New Animal Drugs; Firocoxib Tablets,

[Federal Register: January 16, 2008 (Volume 73, Number 11)]

[Rules and Regulations]

[Page 2808]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr16ja08-7]

[[Page 2808]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs; Firocoxib Tablets

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 a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides for veterinary prescription use of firocoxib chewable tablets in dogs for the control of postoperative pain and inflammation associated with soft-tissue surgery.

DATES: This rule is effective January 16, 2008.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640, filed a supplement to NADA 141-230 for PREVICOX (firocoxib) Chewable Tablets. The supplemental application provides for the veterinary prescription use of firocoxib chewable tablets in dogs for the control of postoperative pain and inflammation associated with soft-tissue surgery. The NADA is approved as of December 18, 2007, and the regulations in 21 CFR 520.928 are 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.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning on the date of approval.

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.

0 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. 520.928, revise paragraphs (c)(1) and (c)(2) to read as follows:

Sec. 520.928 Firocoxib tablets.

* * * * *

(c) * * *

(1) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily for osteoarthritis. Administer approximately 2 hours before soft-tissue surgery.

(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis and for the control of postoperative pain and inflammation associated with soft-tissue surgery. * * * * *

Dated: January 4, 2008. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine.

[FR Doc. E8-730 Filed 1-15-08; 8:45 am]

BILLING CODE 4160-01-S