[Federal Register Volume 71, Number 4 (Friday, January 6, 2006)]
[Rules and Regulations]
[Pages 875-876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-90]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Oral Dosage Form New Animal Drugs; Phenylbutazone Powder

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 A & G Pharmaceuticals, Inc. The ANADA 
provides for the veterinary prescription use of phenylbutazone powder 
administered to horses in feed for the relief of inflammatory 
conditions associated with the musculoskeletal system.

DATES: This rule is effective January 6, 2006.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: A & G Pharmaceuticals, Inc., 1030 West 
Commodore Blvd., Jackson, NJ 08527, filed ANADA 200-334 that provides 
for the veterinary prescription use of EQUIZONE 100 (phenylbutazone), a 
powder administered to horses in feed for the relief of inflammatory 
conditions associated with the musculoskeletal system. A & G 
Pharmaceuticals, Inc.'s, EQUIZONE 100 is approved as a generic copy of 
Phoenix Scientific, Inc.'s, Phenylbutazone Tablets, USP, approved under 
NADA 91-818. The ANADA is approved as of November 18, 2005, and the 
regulations are amended in 21 CFR part 520 by adding new Sec.  
520.1720e. The basis of approval is discussed in the freedom of 
information summary.
    In addition, A & G Pharmaceuticals, Inc., has not been previously 
listed in the animal drug regulations as a sponsor of an approved 
application. At this time, 21 CFR 510.600(c) is being amended to add 
entries for the firm.
    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 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.
    FDA 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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

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 parts 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding a new entry for ``A & G Pharmaceuticals, Inc.'' 
and in the table in paragraph (c)(2) by numerically adding a new entry 
for ``057699'' to read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
A & G Pharmaceuticals, Inc., 1030 West        057699
 Commodore Blvd., Jackson, NJ 08527.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *

[[Page 876]]

 
057699                       A & G Pharmaceuticals, Inc., 1030 West
                              Commodore Blvd., Jackson, NJ 08527
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
4. Section 520.1720e is added to read as follows:


Sec.  520.1720e  Phenylbutazone powder.

    (a) Specifications. Each 10 grams (g) of powder contains 1 g 
phenylbutazone.
    (b) Sponsor. See No. 057699 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1 to 2 g (1 
to 2 level scoops, using the scoop provided) per 500 pounds of body 
weight on a small amount of palatable feed.
    (2) Indications for use. For the relief of inflammatory conditions 
associated with the musculoskeletal system.
    (3) Limitations. Do not exceed 4 g per animal daily. Administer at 
a relatively high dosage level for the first 48 hours, then reduce 
gradually to a maintenance dosage level with the lowest dosage 
maintained at the level capable of producing the desired clinical 
response. Do not use in horses intended for human consumption. Federal 
law prohibits the extralabel use of this product in female cattle 20 
months of age or older. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: December 21, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-90 Filed 1-5-06; 8:45 am]
BILLING CODE 4160-01-S