Document ID: FDA-2013-N-0002-0038
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone
Posted Date: 2013-11-22T05:00Z

[Federal Register Volume 78, Number 226 (Friday, November 22, 2013)]
[Notices]
[Page 70062]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27916]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0002]

Withdrawal of Approval of New Animal Drug Applications; 
Carbarsone; Roxarsone

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of three new animal drug applications (NADAs) for roxarsone or 
carbarsone Type A medicated articles at the sponsor's request because 
the products are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective December 2, 2013.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9079, john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI 
49007, has requested that FDA withdraw approval of the following three 
NADAs because the products, used to manufacture Type B and Type C 
medicated feeds, are no longer manufactured or marketed: NADA 007-891 
for 3-NITRO (roxarsone) Type A medicated article, NADA 092-953 for 
Roxarsone Type A Medicated Articles, and NADA 010-285 for CARB-O-SEP 
(carbarsone) Type A medicated article.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with Sec.  514.116 Notice of withdrawal of approval of 
application (21 CFR 514.116), notice is given that approval of NADAs 
007-891, 092-953, and 010-285, and all supplements and amendments 
thereto, is hereby withdrawn.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary withdrawal of 
approval of these applications.

    Dated: November 18, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-27916 Filed 11-21-13; 8:45 am]
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