2010-27010. Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran

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.

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: [e-mail].

SUPPLEMENTARY INFORMATION:

Fort Dodge Animal Health, a Division of Wyeth Holdings, a Wholly Owned Subsidiary of Pfizer, Inc., 235 East 42d St., 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.	Product	Established name of drug(s)
NADA 11-141	UNISTAT-2 Type A medicated article	nitromide and sulfanitran
NADA 14-250	NOVASTAT Type A medicated article	aklomide and sulfanitran
NADA 34-536	ALKOMIX Type A medicated article ALKOMIX-3 Type A medicated article	aklomide aklomide, sulfanitran, and roxarsone
NADA 34-537	NOVASTAT-3 Type A medicated article	aklomide, sulfanitran, and roxarsone
NADA 35-388	NOVASTAT-W Soluble Powder	aklomide and sulfanitran
NADA 39-666	UNISTAT-3 Type A medicated article	nitromide, sulfanitran, and roxarsone
NADA 44-015	TRAMISOL Type A medicated article	levamisole
NADA 45-455	TRAMISOL Type A medicated article	levamisole

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14-250, 34-536, 34-537, 35-388, 39-666, 44-015, and 45-455, and all supplements and amendments thereto, is hereby withdrawn, effective November 5, 2010.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

Dated: October 8, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.