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Withdrawal of Approval of New Animal Drug Applications; Ketamine; S-Methoprene; Nitazoxanide

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA) listed in table 1 of this document. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs and ANADA.


Withdrawal of approval is effective August 3, 2009.

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John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079, e-mail:

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The following sponsors have requested that FDA withdraw approval of the two NADAs and ANADA listed in table 1 of this document because the products are no longer manufactured or marketed:

Table 1.

SponsorNADA/ANADA Number Product (Drug)21 CFR Cite Affected (Sponsor Drug Labeler Code)
Wellmark International, 1501 East Woodfield Rd., suite 200, West Schaumburg, IL 60173NADA 141-162 Zodiac Fleatrol Flea Caps (S-methoprene)520.1390 (011536)
IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409NADA 141-178 NAVIGATOR Paste (nitazoxanide)520.1498 (065274)
Abbott Laboratories, North Chicago, IL 60064ANADA 200-279 KETAFLO Injection (ketamine HCl, USP)522.1222a (000074)

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that approval of NADAs 141-162 and 141-178, and ANADA 200-279, and all supplements and amendments thereto, are hereby withdrawn, effective August 3, 2009.

In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs.

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Dated: July 14, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. E9-17408 Filed 7-21-09; 8:45 am]