02-3682. Oral 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 supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for a once daily, 2-milligram per pound (mg/lb) dosage of carprofen, by oral chewable tablet, for the relief of pain and inflammation associated with osteoarthritis in dogs.

DATES:

This rule is effective February 14, 2002.

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 a supplement to approved NADA 141-111 that provides for veterinary prescription use of RIMADYL (carprofen) Chewable Tablets for the relief of pain and inflammation associated with osteoarthritis in dogs. The supplemental NADA provides for a once daily, 2-mg/lb dosage for the oral chewable tablet dosage form. The supplemental application is approved as of November 26, 2001, and the regulations are amended in 21 CFR 520.309 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.

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, 21 CFR part 520 is amended as follows:

PART 520-ORAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 520 continues to read as follows:

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

2. Section 520.309 is amended in paragraph (a) by removing “of” and by revising paragraph (d)(1) to read as follows:

§ 520.309

Carprofen.

* * * * *

(d) * * *

(1) Amount. 2 mg per pound (/lb) of body weight once daily or 1 mg/lb twice daily.

* * * * *

Dated: February 5, 2002.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.