[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