06-993. Oral Dosage Form New Animal Drugs; Firocoxib Paste

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 new animal drug application (NADA) filed by Merial Ltd. The NADA provides for veterinary prescription use of firocoxib oral paste in horses for the control of pain and inflammation associated with osteoarthritis.

DATES:

This rule is effective February 3, 2006.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640, filed NADA 141-253 for veterinary prescription use of EQUIOXX (firocoxib) oral paste for the control of pain and inflammation associated with osteoarthritis in horses. The NADA is approved as of December 30, 2005, and 21 CFR part 520 is amended by adding new § 520.930 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

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)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning December 30, 2005.

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

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,

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for

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

2. Revise the section heading of § 520.928 to read as follows:

§ 520.928

Firocoxib tablets.

3. Add § 520.930 to read as follows:

§ 520.930

Firocoxib paste.

(a) Specifications. Each milligram (mg) of paste contains 0.82 mg firocoxib.

(b) Sponsors. See No. 050604 in § 510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. 0.1 mg per kilogram (0.045 mg per pound) body weight daily for up to 14 days.

(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: January 18, 2006.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.