03-12041. Implantation or Injectable Dosage Form New Animal Drugs; Carprofen

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 Pfizer, Inc. The NADA provides for the veterinary prescription use of carprofen solution in dogs, by subcutaneous injection, for the relief of pain and inflammation associated with osteoarthritis.

DATES:

This rule is effective May 15, 2003.

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:

Pfizer, Inc., 235 East 42d St., New York, NY 10017-5755, filed NADA 141-199 for RIMADYL (carprofen) Injection. The NADA provides for the veterinary prescription use of carprofen solution in dogs, by subcutaneous injection, for the relief of pain and inflammation associated with osteoarthritis. The application is approved as of March 3, 2003, and the regulations in part 522 (21 CFR part 522) are amended by adding new § 522.312 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 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 Dockets Management Branch (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 March 3, 2003.

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 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. Section 522.312 is added to read as follows:

§ 522.312

Carprofen.

(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) carprofen.

(b) Sponsor. See No. 000069 in § 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use in dogs—(1) Amount. 1 mg per pound (2.2 mg per kilogram) body weight twice daily, by subcutaneous injection.

(2) Indications for use. For the relief 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: May 6, 2003.

Steven F. Sundlof,

Director, Center for Veterinary Medicine.