75 FR 206 pgs. 65642-65643 - Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran
Type: NOTICEVolume: 75Number: 206Pages: 65642 - 65643
Docket number: [Docket No. FDA-2010-N-0511]
FR document: [FR Doc. 2010-27010 Filed 10-25-10; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0511]
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: john.bartkowiak@fda.hhs.gov.
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.
| 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.
[FR Doc. 2010-27010 Filed 10-25-10; 8:45 am]
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