This PDF is the current document as it appeared on Public Inspection on 12/26/2013 at 08:45 am.
Food and Drug Administration, HHS.
Notice of withdrawal.
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.
Withdrawal of approval is effective January 6, 2014.Start Further Info
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, email@example.com.End Further Info End Preamble Start Supplemental 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:
|006-019||Zuco Poultry Tablets.|
|006-081||Korum Improved Formula.|
|008-274||Pig Scour Tablets.|
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of NADAs 005-414, 006-019, 006-081, 008-274, and 093-025, and all supplements and amendments thereto, is hereby withdrawn, effective January 6, 2014.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.Start Signature
Dated: December 20, 2013.
Director, Center for Veterinary Medicine.
[FR Doc. 2013-30837 Filed 12-26-13; 8:45 am]
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