Document ID: FDA-2008-N-0039-0079
Agency: fda
Document Type: Notice
Title: Approval of Original Abbreviated New Animal Drug Application; Phenylbutazone Tablets
Posted Date: 2008-11-12T05:00Z

[Federal Register: November 12, 2008 (Volume 73, Number 219)]
[Notices]               
[Page 66906-66907]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12no08-96]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0039]

 
Notice of Approval of Original Abbreviated New Animal Drug 
Application; Phenylbutazone Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice 
that it has approved an original abbreviated new animal drug 
application (ANADA) filed by First Priority, Inc. The ANADA provides 
for veterinary prescription use of phenylbutazone tablets in horses for 
the relief of inflammatory conditions associated with the 
musculoskeletal system.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr., 
Elgin, IL 60123, filed ANADA 200-433 providing for veterinary 
prescription use of Phenylbutazone Tablets in horses for the relief of 
inflammatory conditions associated with the musculoskeletal system. 
First Priority, Inc.'s, ANADA for Phenylbutazone Tablets is approved as 
a generic copy of First Priority, Inc.'s, PRIBUTAZONE Tablets, approved 
under NADA 48-647. In accordance with section 512(i) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) and part 514 (21 CFR 
part 514), in Sec. Sec.  514.105(a) and 514.106(a), the Center for 
Veterinary Medicine is providing notice that this ANADA is approved as 
of October 23, 2008.
    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

[[Page 66907]]

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.

    Dated: November 5, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-26793 Filed 11-10-08; 8:45 am]

BILLING CODE 4160-01-S