Document ID: FDA-2009-N-0302-0001
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of New Animal Drug Applications; Ketamine; S-Methoprene; Nitazoxanide
Posted Date: 2009-07-22T04:00Z

[Federal Register: July 22, 2009 (Volume 74, Number 139)]
[Notices]               
[Page 36241]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jy09-93]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0302]

 
Withdrawal of Approval of New Animal Drug Applications; Ketamine; 
S-Methoprene; Nitazoxanide

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of two new animal drug applications (NADAs) and an abbreviated new 
animal drug application (ANADA) listed in table 1 of this document. 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 and ANADA.

DATES:  Withdrawal of approval is effective August 3, 2009.

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: The following sponsors have requested that 
FDA withdraw approval of the two NADAs and ANADA listed in table 1 of 
this document because the products are no longer manufactured or 
marketed:

                                 Table 1.
------------------------------------------------------------------------
                                                   21 CFR Cite Affected
        Sponsor             NADA/ANADA Number      (Sponsor Drug Labeler
                              Product (Drug)               Code)
------------------------------------------------------------------------
Wellmark International,  NADA 141-162             520.1390 (011536)
 1501 East Woodfield     Zodiac Fleatrol Flea
 Rd., suite 200, West     Caps (S-methoprene)
 Schaumburg, IL 60173
------------------------------------------------------------------------
IDEXX Pharmaceuticals,   NADA 141-178             520.1498 (065274)
 Inc., 7009 Albert Pick  NAVIGATOR Paste
 Rd., Greensboro, NC      (nitazoxanide)
 27409
------------------------------------------------------------------------
Abbott Laboratories,     ANADA 200-279            522.1222a (000074)
 North Chicago, IL       KETAFLO Injection
 60064                    (ketamine HCl, USP)
------------------------------------------------------------------------

    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 
141-162 and 141-178, and ANADA 200-279, and all supplements and 
amendments thereto, are hereby withdrawn, effective August 3, 2009.
    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: July 14, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-17408 Filed 7-21-09; 8:45 am]

BILLING CODE 4160-01-S