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Notice

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

Document Details

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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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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.

DATES:

Withdrawal of approval is effective November 5, 2010.

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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, e-mail: john.bartkowiak@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

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]

BILLING CODE 4160-01-P