Document ID: FDA-2010-N-0002-0037
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of New Animal Drug Applications: Coumaphos; Novobiocin; Buquinolate and Lincomycin
Posted Date: 2010-05-05T04:00Z

[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Notices]               
[Page 24719-24720]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my10-105]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0002]

 
Withdrawal of Approval of New Animal Drug Applications; 
Coumaphos; Novobiocin; Buquinolate and Lincomycin

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of three 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 the single NADA of the three that is codified.

DATES:  Withdrawal of approval is effective May 17, 2010.

[[Page 24720]]

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 three NADAs listed in Table 1:

                                Table 1.
------------------------------------------------------------------------
                             NADA No./Product           21 CFR Cite
        Sponsor            (Established Name of       (Sponsor's Drug
                                  Drug)                Labeler Code)
------------------------------------------------------------------------
Pharmacia & Upjohn      NADA 13-467/ALBAMIX        Not codified
 Co., a Division of      Susceptibility Disks
 Pfizer, Inc., 235      (novobiocin)
 East 42d St., New
 York, NY 10017
------------------------------------------------------------------------
Pharmacia & Upjohn      NADA 45-738/LINCOMIX/      Not codified
 Co., a Division of      BONAID
 Pfizer, Inc., 235      (lincomycin/buquinolate)
 East 42d St., New
 York, NY 10017
------------------------------------------------------------------------
Purina Mills, Inc.,     NADA 42-117/Purina 6 Day   558.185 (017800)
 P.O. Box 66812, St.     Worm-Kill Concentrate
 Louis, MO 63166-6812   (coumaphos)
------------------------------------------------------------------------

    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 
13-467, 42-117, and 45-738, and all supplements and amendments thereto, 
is hereby withdrawn, effective May 17, 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 NADA 42-117.

    Dated: April 30, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-10567 Filed 5-4-10; 8:45 am]
BILLING CODE 4160-01-S