Food and Drug Administration, HHS.
Notification of withdrawal of approval.
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.
Withdrawal of approval is effective March 31, 2014.
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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.
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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:
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|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.|
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 § 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that approval of NADA 039-077, ANADA 200-140, and ANADA 200-167, and all supplements and amendments thereto, is hereby withdrawn, effective March 31, 2014.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.
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Dated: March 12, 2014.
Director, Center for Veterinary Medicine.
[FR Doc. 2014-05883 Filed 3-19-14; 8:45 am]
BILLING CODE 4160-01-P