Document ID: FDA-2010-N-0511-0001
Agency: fda
Document Type: Notice
Title: Withdrawals of Approvals of New Animal Drug Applications: Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran
Posted Date: 2010-10-26T04:00Z

[Federal Register: October 26, 2010 (Volume 75, Number 206)]
[Notices]               
[Page 65642-65643]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc10-76]                         

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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.

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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

[[Page 65643]]

St., New York, NY 10017 has requested that FDA withdraw approval of the 
eight NADAs listed in Table 1 of this document.

                                 Table 1
------------------------------------------------------------------------
                                                     Established name of
          NADA No.                   Product               drug(s)
------------------------------------------------------------------------
NADA 11-141.................  UNISTAT-2 Type A      nitromide and
                               medicated article.    sulfanitran
NADA 14-250.................  NOVASTAT Type A       aklomide and
                               medicated article.    sulfanitran
NADA 34-536.................  ALKOMIX Type A        aklomide
                               medicated article.   aklomide,
                              ALKOMIX-3 Type A       sulfanitran, and
                               medicated article.    roxarsone
NADA 34-537.................  NOVASTAT-3 Type A     aklomide,
                               medicated article.    sulfanitran, and
                                                     roxarsone
NADA 35-388.................  NOVASTAT-W Soluble    aklomide and
                               Powder.               sulfanitran
NADA 39-666.................  UNISTAT-3 Type A      nitromide,
                               medicated article.    sulfanitran, and
                                                     roxarsone
NADA 44-015.................  TRAMISOL Type A       levamisole
                               medicated article.
NADA 45-455.................  TRAMISOL Type A       levamisole
                               medicated article.
------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with Sec.  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]
BILLING CODE 4160-01-P