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.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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.
|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14-250, 34-536, 34-537, 35-388, 39-666, 44-015, and 45-455, and all supplements and amendments thereto, is hereby withdrawn, effective November 5, 2010.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.Start Signature
Dated: October 8, 2010.
Director, Center for Veterinary Medicine.
[FR Doc. 2010-27010 Filed 10-25-10; 8:45 am]
BILLING CODE 4160-01-P