[Federal Register Volume 69, Number 131 (Friday, July 9, 2004)]
[Notices]
[Page 41509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15570]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Notice of Approval of Abbreviated New Animal Drug Application; 
Oxytocin 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 
oxytocin injectable solution in ewes, sows, cows, and horses. The 
applicable section of the regulation 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 200-328 filed by Cross Vetpharm Group, Ltd., Broomhill 
Rd., Tallaght, Dublin 24, Ireland. ANADA 200-328 provides for the 
veterinary prescription use of Oxytocin Injection in ewes, sows, cows, 
and horses. Cross Vetpharm Group's Oxytocin Injection is approved as a 
generic copy of Phoenix Scientific, Inc.'s PVL Oxytocin Injectable, 
approved under NADA 124-241. The ANADA is approved as of May 21, 2004. 
The basis of approval is discussed in the freedom of information 
summary. The applicable sections of the regulation did not require 
amendment.
    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 14, 2004.
Linda Tollefson,
Acting Center Director, Center for Veterinary Medicine.
[FR Doc. 04-15570 Filed 7-8-04; 8:45 am]
BILLING CODE 4160-01-S