[Federal Register Volume 70, Number 102 (Friday, May 27, 2005)]
[Rules and Regulations]
[Pages 30625-30626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10627]


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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 an abbreviated new animal drug 
application (ANADA) filed by IMPAX Laboratories, Inc. The ANADA 
provides for veterinary prescription use of carprofen caplets in dogs 
for the relief of pain and inflammation associated with osteoarthritis.

DATES: This rule is effective May 27, 2005.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: IMPAX Laboratories, Inc., 30831 Huntwood 
Ave., Hayward, CA 94544, filed ANADA 200-366 for veterinary 
prescription use of Carprofen Caplets in dogs for the relief of pain 
and inflammation associated with osteoarthritis. IMPAX Laboratories, 
Inc.'s Carprofen Caplets is approved as a generic copy of Pfizer, 
Inc.'s RIMADYL Caplets, approved under NADA 141-053. ANADA 200-366 is 
approved as of April 27, 2005, and 21 CFR 520.309 is amended 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 21 CFR 514.11(e)(2)(ii), a

[[Page 30626]]

summary of safety and effectiveness data and information submitted to 
support approval of this application may be seen in the Division of 
Dockets Management (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(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.

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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

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

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

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2. Section 520.309 is amended by revising paragraphs (b) and (d)(2) to 
read as follows:


Sec.  520.309  Carprofen.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
    (1) No. 000069 for use of products described in paragraph (a) of 
this section as in paragraph (d) of this section.
    (2) No. 000115 for use of product described in paragraph (a)(1) of 
this section as in paragraphs (d)(1), (d)(2)(i), and (d)(3) of this 
section.
* * * * *
    (d) * * *
    (2) Indications for use--(i) For the relief of pain and 
inflammation associated with osteoarthritis.
    (ii) For the control of postoperative pain associated with soft 
tissue and orthopedic surgery.
* * * * *

    Dated: May 13, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-10627 Filed 5-26-05; 8:45 am]
BILLING CODE 4160-01-S