Document ID: FDA-2013-N-0002-0049
Agency: fda
Document Type: Rule
Title: Approvals of New Animal Drug Applications Withdrawals Roxarsone
Posted Date: 2013-12-27T05:00Z

[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Rules and Regulations]
[Page 78716]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30837]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

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

Withdrawal of Approval of New Animal Drug Applications; Roxarsone

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of five new animal drug applications (NADAs) for roxarsone oral dosage 
form products at the sponsor's request because the products are no 
longer manufactured or marketed.

DATES: Withdrawal of approval is effective January 6, 2014.

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 five 
NADAs for roxarsone oral dosage form products, used to make medicated 
drinking water for chickens, turkeys, and swine, because the products 
are no longer manufactured or marketed:

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               NADA                           Proprietary name
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005-414..........................  REN-O-SAL Tablets.
006-019..........................  Zuco Poultry Tablets.
006-081..........................  Korum Improved Formula.
008-274..........................  Pig Scour Tablets.
093-025..........................  3-NITRO Soluble.
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    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 
005-414, 006-019, 006-081, 008-274, and 093-025, and all supplements 
and amendments thereto, is hereby withdrawn, effective January 6, 2014.
    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: December 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-30837 Filed 12-26-13; 8:45 am]
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