[Federal Register Volume 68, Number 223 (Wednesday, November 19, 2003)]
[Rules and Regulations]
[Pages 65168-65169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28872]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Dexamethasone Injection

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 Cross Vetpharm Group, Ltd. The ANADA 
provides for the veterinary prescription use of dexamethasone 
injectable solution in dogs, cats, cattle, and horses.

DATES:  This rule is effective November 19, 2003.

FOR FURTHER INFORMATION CONTACT:  Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-312 that provides for use 
of DEXIUM (dexamethasone) Solution for the treatment of primary bovine 
ketosis and as an anti-inflammatory agent in dogs, cats, cattle, and 
horses. Cross Vetpharm Group's DEXIUM Solution is approved as a generic 
copy of Schering-Plough Animal Health's AZIUM Solution 2 milligrams, 
approved under NADA 12-559. The ANADA is approved as of October 20, 
2003, and the regulations are amended in 21 CFR 522.540 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 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

[[Page 65169]]

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 Subject in 21 CFR Part 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


Sec.  522.540  [Amended]

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2. Section 522.540 Dexamethasone injection is amended in paragraph 
(a)(2)(i) by removing ``and 059130'' and by adding in its place ``, 
059130, and 061623''.

    Dated: November 3, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-28872 Filed 11-18-03; 8:45 am]
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