Oral Dosage Form New Animal Drugs: Firocoxib Tablets

Federal Register: October 31, 2008 (Volume 73, Number 212)

Rules and Regulations

Page 64885

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

DOCID:fr31oc08-10

Page 64885

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 520

Docket No. FDA-2008-N-0039

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 orthopedic surgery.

DATES: This rule is effective October 31, 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 orthopedic surgery. The NADA is approved as of

September 23, 2008, 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

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(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 or orthopedic 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 and orthopedic surgery.

* * * * *

Dated: October 17, 2008.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

FR Doc. E8-26020 Filed 10-30-08; 8:45 am

BILLING CODE 4160-01-P