[Federal Register Volume 69, Number 117 (Friday, June 18, 2004)]
[Notices]
[Page 34175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Notice of Approval of Abbreviated New Animal Drug Application; 
Dexamethasone Sodium Phosphate Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's Center for Veterinary 
Medicine (CVM) is providing notice that it has approved an original 
abbreviated new animal drug application (ANADA) filed by Cross Vetpharm 
Group Ltd. The ANADA provides for the veterinary prescription use of 
dexamethasone sodium phosphate injectable solution as a rapid adrenal 
glucocorticoid and/or anti-inflammatory agent in horses. The applicable 
sections of the regulations did not require amendment.

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: In accordance with section 512(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) and 21 CFR 
514.105(a) and 514.106(a), CVM is providing notice that it has approved 
original ANADA 200-317 filed by Cross Vetpharm Group Ltd., Broomhill 
Rd., Tallaght, Dublin 24, Ireland. ANADA 200-317 provides for the 
veterinary prescription use of DEXIUM-SP (dexamethasone sodium 
phosphate) Injection as a rapid adrenal glucocorticoid and/or anti-
inflammatory agent in horses. Cross Vetpharm Group's DEXIUM-SP 
Injection is approved as a generic copy of Steris Laboratories, Inc.'s 
Dexamethasone Injection, approved under NADA 104-606. The ANADA is 
approved as of April 29, 2004. 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 nor an environmental impact statement is 
required.

    Dated: June 4, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-13790 Filed 6-17-04; 8:45 am]
BILLING CODE 4160-01-S