Document ID: FDA-2014-N-0002-0015
Agency: fda
Document Type: Rule
Title: Withdrawal of Approval of New Animal Drug Applications; Chlortetracycline; Sulfathiazole; Penicillin
Posted Date: 2014-03-20T04:00Z

[Federal Register Volume 79, Number 54 (Thursday, March 20, 2014)]
[Rules and Regulations]
[Pages 15540-15541]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05883]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2014-N-0002]

Withdrawal of Approval of New Animal Drug Applications; 
Chlortetracycline; Sulfathiazole; Penicillin

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal of approval.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA) and two abbreviated new animal 
drug applications (ANADAs) for three-way, fixed-ratio combination drug 
Type A medicated articles containing chlortetracycline, sulfathiazole, 
and penicillin. This action is being taken at the sponsor's request 
because these products are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective March 31, 2014.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6843.

SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI 
49007 has requested that FDA withdraw approval of the following NADA 
and two ANADAs because the products are no longer manufactured or 
marketed:

------------------------------------------------------------------------
                NADA/ANADA                        Proprietary name
------------------------------------------------------------------------
039-077...................................  CSP 250 (chlortetracycline,
                                             sulfathiazole, and
                                             penicillin) Type A
                                             medicated article.
200-140...................................  AUREOZOL (chlortetracycline,
                                             sulfathiazole, and
                                             penicillin) Type A
                                             medicated article.
200-167...................................  AUREOZOL 500 Granular
                                             (chlortetracycline,
                                             sulfathiazole, and
                                             penicillin) Type A
                                             medicated article.
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[[Page 15541]]

    The NADAs listed were identified as being affected by guidance for 
industry (GFI) 213, ``New Animal Drugs and New Animal Drug 
Combination Products Administered in or on Medicated Feed or Drinking 
Water of Food-Producing Animals: Recommendations for Drug Sponsors for 
Voluntarily Aligning Product Use Conditions with GFI 209'', 
December 2013.
    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 NADA 
039-077, ANADA 200-140, and ANADA 200-167, and all supplements and 
amendments thereto, is hereby withdrawn, effective March 31, 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: March 12, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-05883 Filed 3-19-14; 8:45 am]
BILLING CODE 4160-01-P