[Federal Register Volume 64, Number 115 (Wednesday, June 16, 1999)]
[Rules and Regulations]
[Pages 32180-32181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15291]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Carprofen
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 veterinary
prescription use of carprofen chewable tablets for the relief of pain
and inflammation associated with osteoarthritis in dogs.
EFFECTIVE DATE: June 16, 1999.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7543.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York,
NY 10017-5755, filed NADA 141-111 that provides for oral veterinary
prescription use of Rimadyl (carprofen) chewable tablets for
the relief of pain and inflammation associated with osteoarthritis in
dogs. The NADA is approved as of May 14, 1999. The regulations are
amended in 21 CFR 520.309 by revising the section heading, by revising
paragraph (a), by redesignating paragraph (c) as paragraph (d), by
reserving paragraph (c), and by revising newly redesignated paragraphs
(d)(1) and (d)(2) to reflect the approval.
The regulations currently provide for use of carprofen caplets in
NADA 141-053. A revision of the indications for use has been approved
by letter of April 21, 1999. At this time, the regulation is amended to
reflect that approval.
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 for nonfood-
producing animals qualifies for 3 years of marketing
[[Page 32181]]
exclusivity beginning May 14, 1999, because the application contains
substantial evidence of the effectiveness of the drug involved, or any
studies of animal safety required for approval of the application and
conducted or sponsored by the applicant. Three years of marketing
exclusivity applies only to use of carprofen chewable tablets for
relief of pain and inflammation associated with osteoarthritis in dogs.
The agency has determined under 21 CFR 25.33(a)(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 by revising the section heading, by
revising paragraph (a), by redesignating paragraph (c) as paragraph
(d), by reserving paragraph (c), and by revising newly redesignated
paragraphs (d)(1) and (d)(2) to read as follows:
Sec. 520.309 Carprofen.
(a) Specifications. Each caplet or chewable tablet contains 25, 75,
or 100 milligrams of carprofen.
* * * * *
(c) [Reserved]
(d) * * *
(1) Amount. 1 milligram per pound of body weight twice daily.
Caplets and chewable tablets are scored and dosage should be calculated
and given in half-caplet or half-chewable tablet increments.
(2) Indications for use. For the relief of pain and inflammation
associated with osteoarthritis in dogs.
* * * * *
Dated: June 4, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-15291 Filed 6-15-99; 8:45 am]
BILLING CODE 4160-01-F
