Document ID: FDA-2010-N-0425-0001
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of New Animal Drug Applications: Chloramphenicol; Lincomycin; Pyrantel Tartrate; and Tylosin Phosphate andSulfamethazine
Posted Date: 2010-09-14T04:00Z

[Federal Register: September 14, 2010 (Volume 75, Number 177)]
[Notices]               
[Page 55810]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14se10-93]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0425]

 
Withdrawal of Approval of New Animal Drug Applications; 
Chloramphenicol, Lincomycin, Pyrantel Tartrate, and Tylosin Phosphate 
and Sulfamethazine

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of four new animal drug applications (NADAs). In a final rule published 
elsewhere in this issue of the Federal Register, FDA is amending the 
regulations to remove portions reflecting approval of these NADAs.

DATES:  Withdrawal of approval is effective September 24, 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, email: john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: John J. Ferrante, 11 Fairway Lane, Trumbull, 
CT 06611; International Nutrition, Inc., 7706 ``I'' Plaza, Omaha, NE 
68127; and Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, 
Mankato, MN 56001 have requested that FDA withdraw approval of the four 
NADAs listed in table 1 because they are no longer manufactured or 
marketed:

                                Table 1.
------------------------------------------------------------------------
                           NADA Number Product          21 CFR Cite
        Sponsor            (Established Name of       (Sponsor's Drug
                                  Drug)                Labeler Code)
------------------------------------------------------------------------
John J. Ferrante, 11    NADA 65-137 AMPHICOL-V     Sec.   520.390b
 Fairway Lane,           Capsules                   (058034)
 Trumbull, CT 06611      (chloramphenicol)
------------------------------------------------------------------------
International           NADA 121-337 INI Swine     Sec.   558.485
 Nutrition, Inc., 7706   Ban-Wormer B-9.6 BA.       (043733)
 ``I'' Plaza, Omaha,     (pyrantel tartrate)
 NE 68127
------------------------------------------------------------------------
International           NADA 132-923 LINCO 8/      Sec.   558.325
 Nutrition, Inc., 7706   LINCO 20 (lincomycin)      (043733)
 ``I'' Plaza, Omaha,
 NE 68127
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Feed Service Co.,       NADA 138-342 TYLAN 5       Sec.   558.630
 Inc., 303 Lundin        Sulfa-G Premix (tylosin    (030841)
 Blvd., P.O. Box 698,    and sulfamethazine)
 Mankato, MN 56001
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    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 
65-137, 121-337, 132-923, and 138-342, and all supplements and 
amendments thereto, is hereby withdrawn, effective September 24, 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: September 1, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-22809 Filed 9-13-10; 8:45 am]
BILLING CODE 4160-01-S