Document ID: FDA-2011-N-0033-0001
Agency: fda
Document Type: Notice
Title: Withdrawals of Approvals of New Animal Drug Applications: Phenylbutazone; Pyrantel; Tylosin; Sulfamethazine
Posted Date: 2011-03-02T05:00Z

[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Page 11490]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4545]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0033]

Withdrawal of Approval of New Animal Drug Applications; 
Phenylbutazone; Pyrantel; Tylosin; Sulfamethazine

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 regulations to remove portions reflecting approval of 
these NADAs.

DATES: Withdrawal of approval is effective March 14, 2011.

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 sponsors in table 1 have requested that 
FDA withdraw approval of the three NADAs listed because the products 
are no longer manufactured or marketed.

  Table 1--Voluntary Requests for Withdrawal of Approval (WOA) of Three
                                  NADAs
------------------------------------------------------------------------
                                NADA No. product       21 CFR Section
           Sponsor            (established name of    affected (sponsor
                                      drug)          drug labeler code)
------------------------------------------------------------------------
First Priority, Inc., 1590    NADA 48-647,          520.1720a (058829).
 Todd Farm Dr., Elgin, IL      Phenylbutazone
 60123.                        boluses
                               (phenylbutazone).
Yoder Feed, Division of       NADA 96-161, Hy-Con   558.625 (035369).
 Yoder, Inc., Kalona, IA       TYLAN Premix
 52247.                        (tylosin phosphate).
Triple ``F'', Inc., 10104     NADA 119-062, Cadco-  558.485 (011490).
 Douglas Ave., Des Moines,     BN-10 BANMINTH
 IA 50322.                     Premix (pyrantel
                               tartrate).
------------------------------------------------------------------------

    Truow Nutrition, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 (Truow), 
has informed FDA that it is the sponsor of five feed premix NADAs 
previously owned by milling companies, which it purchased. NADA 100-352 
was owned by NutriBasics Co., last doing business at P.O. Box 1014, 
Willmar, MN 56201. NADA 107-002 and NADA 123-000 were owned by Seeco, 
Inc., also last doing business at P.O. Box 1014, Willmar, MN 56201. 
NADA 133-833 and NADA 135-243 were owned by Southern Micro-Blenders, 
Inc., last doing business at 3801 North Hawthorne St., Chattanooga, TN 
37406. Truow has requested that FDA withdraw approval of the five NADAs 
in table 2 because they are no longer manufactured or marketed.

                   Table 2--Voluntary Requests for WOA of Five NADAs by Truow Nutrition, Inc.
----------------------------------------------------------------------------------------------------------------
                                           NADA No., product  (established   21 CFR section  affected  (sponsor
            Previous sponsor                        name of drug)                    drug  labeler code)
----------------------------------------------------------------------------------------------------------------
NutriBasics Co., North Highway 71, P.O.   NADA 100-352, Seeco T-10 Premix   558.625 (053740).
 Box 1014, Willmar, MN 56201.              (tylosin phosphate).
Seeco, Inc., P.O. Box 1014, North         NADA 107-002, Seeco TYLAN-Sulfa   Not codified.
 Highway 71, Willmar, MN 56201.            10 Premix (tylosin phosphate
                                           and sulfamethazine).
Seeco, Inc., P.O. Box 1014, North         NADA 123-000, Super Swine Wormer  558.485 (011749).
 Highway 71, Willmar, MN 56201.            B-9 BANMINTH (pyrantel
                                           tartrate).
Southern Micro-Blenders, Inc., 3801       NADA 133-833, TYLAN 10 Premix     558.625 (049685).
 North Hawthorne St., Chattanooga, TN      (tylosin phosphate).
 37406.
Southern Micro-Blenders, Inc., 3801       NADA 135-243, Swine Guard-BN      558.485 (049685).
 North Hawthorne St., Chattanooga, TN      BANMINTH Premix (pyrantel
 37406.                                    tartrate).
----------------------------------------------------------------------------------------------------------------

    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 
48-647, 96-161, 100-352, 107-002, 119-062, 123-000, 133-833, and 135-
243, and all supplements and amendments thereto, is hereby withdrawn, 
effective March 14, 2011.
    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: February 18, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-4545 Filed 3-1-11; 8:45 am]
BILLING CODE 4160-01-P