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Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs). 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.


Withdrawal of approval is effective November 5, 2010.

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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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Fort Dodge Animal Health, a Division of Wyeth Holdings, a Wholly Owned Subsidiary of Pfizer, Inc., 235 East 42d Start Printed Page 65643St., New York, NY 10017 has requested that FDA withdraw approval of the eight NADAs listed in Table 1 of this document.

Table 1

NADA No.ProductEstablished name of drug(s)
NADA 11-141UNISTAT-2 Type A medicated articlenitromide and sulfanitran
NADA 14-250NOVASTAT Type A medicated articleaklomide and sulfanitran
NADA 34-536ALKOMIX Type A medicated article ALKOMIX-3 Type A medicated articleaklomide aklomide, sulfanitran, and roxarsone
NADA 34-537NOVASTAT-3 Type A medicated articleaklomide, sulfanitran, and roxarsone
NADA 35-388NOVASTAT-W Soluble Powderaklomide and sulfanitran
NADA 39-666UNISTAT-3 Type A medicated articlenitromide, sulfanitran, and roxarsone
NADA 44-015TRAMISOL Type A medicated articlelevamisole
NADA 45-455TRAMISOL Type A medicated articlelevamisole

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 11-141, 14-250, 34-536, 34-537, 35-388, 39-666, 44-015, and 45-455, and all supplements and amendments thereto, is hereby withdrawn, effective November 5, 2010.

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: October 8, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. 2010-27010 Filed 10-25-10; 8:45 am]