E7-17645. Implantation or Injectable Dosage Form New Animal Drugs; Etodolac

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 Fort Dodge Animal Health, Division of Wyeth. The NADA provides for veterinary prescription use of etodolac injectable solution in dogs for the control of pain and inflammation associated with osteoarthritis.

DATES:

This rule is effective September 7, 2007.

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:

Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501 filed NADA 141-274 that provides for veterinary prescription use of ETOGESIC (etodolac) Injectable in dogs for the control of pain and inflammation associated with osteoarthritis. The application is approved as of August 16, 2007, and part 522 (21 CFR part 522) is amended by adding § 522.870 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)(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 on the date of approval.

FDA 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 522

• 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 522 is amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 522 continues to read as follows:

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

2. Add § 522.870 to read as follows:

§ 522.870

Etodolac.

(a) Specifications. Each milliliter contains 100 milligrams (mg) etodolac.

(b) Sponsor. See No. 000856 in § 510.600 of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer 4.5 to 6.8 mg/pound (10 to 15 mg/kilogram) body weight as a single, dorsoscapular subcutaneous injection. If needed, the daily dose of etodolac tablets as in § 520.870 of this chapter may be given 24 hours after the injection.

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

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: August 28, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.