[Federal Register Volume 61, Number 244 (Wednesday, December 18, 1996)]
[Rules and Regulations]
[Page 66581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32068]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520


Oral Dosage Form New Animal Drugs; Carprofen Caplets

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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 oral use of 
nonsteroidal anti-inflammatory carprofen caplets in dogs for relief of 
pain and inflammation. Carprofen has been shown to be clinically 
effective for the relief of signs associated with osteoarthritis.

EFFECTIVE DATE: December 18, 1996.

FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for 
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0614.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed NADA 141-053, which provides for oral use of carprofen 
caplets in dogs for the relief of pain and inflammation. Carprofen has 
been shown to be clinically effective for the relief of signs 
associated with osteoarthritis. The drug product is restricted to 
veterinary prescription use only. The NADA is approved as of October 
25, 1996, and the regulations are amended by adding new 21 CFR 520.309 
to reflect the approval. The basis for 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 Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning October 25, 1996, because no 
active ingredient (including any ester or salt thereof) of the drug has 
been approved previously in any other NADA.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. New Sec. 520.309 is added to read as follows:


Sec. 520.309  Carprofen caplets.

    (a) Specification. Each caplet contains 25, 75, or 100 milligrams 
of carprofen.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 1 milligram per pound of 
body weight twice daily. Caplets are scored and dosage should be 
calculated in half-caplet increments.
    (2) Indications for use. For the relief of pain and inflammation in 
dogs. Carprofen has been shown to be clinically effective for the 
relief of signs associated with osteoarthritis in dogs.
    (3) Limitations. The safe use of carprofen in pregnant dogs, dogs 
used for breeding purposes, or in lactating bitches has not been 
established. As a class, cyclo-oxygenase inhibitory nonsteroidal anti-
inflammatory drugs (NSAID's) may be associated with gastrointestinal 
and renal toxicity. Patients at greatest risk for renal toxicity are 
those on concomitant diuretic therapy, or those with renal, 
cardiovascular, and/or hepatic dysfunction. Because many NSAID's 
possess the potential to induce gastrointestinal ulceration, avoid or 
closely monitor concomitant use of carprofen with other anti-
inflammatory drugs, such as corticosteroids and NSAID's. Carprofen 
treatment was not associated with renal toxicity or gastrointestinal 
ulceration in safety studies of up to 10 times the dose in dogs. Do not 
use in dogs with bleeding disorders (e.g., Von Willebrand's disease). 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: December 6, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-32068 Filed 12-17-96; 8:45 am]
BILLING CODE 4160-01-F