78 FR 226 pg. 70062 - Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone
Type: NOTICEVolume: 78Number: 226Page: 70062
Page: 70062Docket number: [Docket No. FDA-2013-N-0002]
FR document: [FR Doc. 2013-27916 Filed 11-21-13; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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 § 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is given that approval of NADAs 007-891, 092-953, and 010-285, and all supplements and amendments thereto, is hereby withdrawn.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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