Document ID: FDA-2008-N-0039-0008
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets
Posted Date: 2008-02-13T05:00Z

[Federal Register: February 13, 2008 (Volume 73, Number 30)]
[Rules and Regulations]               
[Page 8192]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13fe08-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

 
Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets

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 two supplemental new animal 
drug applications (NADAs) filed by IVX Animal Health, Inc. The 
supplemental NADAs provide revised labeling for phenylbutazone tablets 
used in horses and dogs.

DATES: This rule is effective February 13, 2008.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed supplements to NADA 91-818 and 
NADA 94-170 for Phenylbutazone Tablets. The supplemental applications 
provide for revisions to warning statements on product labeling. The 
supplemental NADAs are approved as of January 17, 2008, and 21 CFR 
520.1720a is amended to reflect the approval.
    Approval of these supplemental NADAs did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33(a)(1) that these 
actions are of a type that do 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.

0
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.

0
2. Revise Sec.  520.1720a to read as follows:

Sec.  520.1720a  Phenylbutazone tablets and boluses.

    (a) Specifications. Each tablet contains 100, 200, or 400 
milligrams (mg), or 1 gram (g) phenylbutazone. Each bolus contains 2 or 
4 g phenylbutazone.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter, as follows:
    (1) No. 000061 for use of 100- or 400-mg or 1-g tablets, or 2- or 
4-g boluses, in dogs and horses.
    (2) Nos. 000010 and 059130 for use of 100- or 200-mg or 1-g tablets 
in dogs and horses.
    (3) Nos. 000856, 058829, and 061623 for use of 100-mg or 1-g 
tablets in dogs and horses.
    (4) No. 055246 for use of 100-mg tablets in dogs.
    (5) No. 000143 for use of 1-g tablets in horses.
    (c) Conditions of use--(1) Dogs--(i) Amount. 20 mg per pound of 
body weight daily.
    (ii) Indications for use. For the relief of inflammatory conditions 
associated with the musculoskeletal system.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. 1 to 2 g per 500 pounds of body weight 
daily.
    (ii) Indications for use. For the relief of inflammatory conditions 
associated with the musculoskeletal system.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law prohibits the use of this drug in female dairy 
cattle 20 months of age or older. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

    Dated: January 31, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-2608 Filed 2-12-08; 8:45 am]

BILLING CODE 4160-01-S