Document ID: FDA-2012-N-1167-0002
Agency: fda
Document Type: Notice
Title: Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications
Posted Date: 2013-03-07T05:00Z

[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Notices]
[Pages 14803-14804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04998]

[[Page 14803]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1167]

Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 19 new animal drug applications (NADAs) and 1 abbreviated new animal 
drug application (ANADA) from multiple holders of these applications. 
The basis for the withdrawals is that the holders of these applications 
have repeatedly failed to file required annual reports for the 
applications.

DATES: Withdrawal of approval is effective March 18, 2013.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6843, david.alterman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The holders of approved applications to 
market new animal drugs are required to submit annual reports to FDA 
concerning each of their approved applications in accordance with Sec.  
514.80 (21 CFR 514.80).
    In the Federal Register of December, 17, 2012 (77 FR 74672), FDA 
published a notice offering an opportunity for a hearing (NOOH) on a 
proposal to withdraw approval of 19 NADAs and 1 ANADA because the 
sponsors had failed to submit the required annual reports for these 
applications. The holders of these applications did not respond to the 
NOOH. Failure to file a written notice of participation and request for 
a hearing as required by Sec.  514.200(b) (21 CFR 514.200(b)) 
constitutes an election by the applicant not to make use of the 
opportunity for a hearing concerning the proposal to withdraw approval 
of the applications and a waiver of any contentions concerning the 
legal status of the drug products. Therefore, the Director, Center for 
Veterinary Medicine, is withdrawing approval of the 20 applications 
listed in Table 1 of this document.

        Table 1--NADAs and ANADA for Which Approval Is Withdrawn
------------------------------------------------------------------------
        Application No.          Trade Name  (drug)       Applicant
------------------------------------------------------------------------
NADA 009-252..................  FUMIDIL B            Mid-Continent
                                 (bicyclohexylammon   Agrimarketing,
                                 ium fumagillin).     Inc., 8833 Quivira
                                                      Rd., Overland
                                                      Park, KS 66214.
NADA 034-601..................  SYNCHRO-MATE         G. D. Searle LLC,
                                 (flurogestone        Pharmacia Corp.,
                                 acetate).            4901 Searle Pkwy.,
                                                      Skokie, IL 60077.
NADA 039-284..................  Swisher Super        Swisher Feed
                                 Broiler 300-108      Division, William
                                 (amprolium,          Davies Co., Inc.,
                                 ethopabate,          P.O. Box 578,
                                 bacitracin zinc,     Danville, IL
                                 and roxarsone).      61832.
NADA 040-920..................  Chick Grower-        Honeggers and Co.,
                                 Developer            Inc., 201 W.
                                 Fortified            Locust St.,
                                 (amprolium).         Fairbury, IL
                                                      61739.
NADA 094-223..................  Canine Worm Caps (n- K. C. Pharmacal,
                                 butyl chloride).     Inc., 8345 Melrose
                                                      Dr., Lenexa, KS
                                                      66214.
NADA 098-429..................  Medic-Meal-T Premix  J. C. Feed Mills,
                                 (tylosin             1050 Sheffield,
                                 phosphate).          P.O. Box 224,
                                                      Waterloo, IA
                                                      50704.
NADA 098-639..................  TYLAN Sulfa-G        Bioproducts, Inc.,
                                 (tylosin phosphate   320 Springside
                                 and                  Dr., suite 300,
                                 sulfamethazine).     Fairlawn, OH 44333-
                                                      2435.
NADA 106-507..................  TYLAN 10 (tylosin    Custom Feed
                                 phosphate).          Blenders Corp.,
                                                      540 Hawkeye Ave.,
                                                      Fort Dodge, IA
                                                      50501.
NADA 110-044..................  PRO-TONE Plus Pak    Peavey Co., 730
                                 GF T-1 (tylosin      Second Ave. South,
                                 phosphate).          Minneapolis, MN
                                                      55402.
NADA 117-688..................  Dichlorophene and    Texas Vitamin Co.,
                                 Toluene Capsules.    P.O. Box 18417,
                                                      10695 Aledo St.,
                                                      Dallas, TX 57218.
NADA 120-614..................  TYLAN Sulfa-G        Webel Feeds, Inc.,
                                 (tylosin phosphate   R.R. 3,
                                 and                  Pittsfield, IL
                                 sulfamethazine).     62363.
NADA 120-671..................  Pet-Worm-Caps        K. C. Pharmacal,
                                 (dichlorophene and   Inc., 8345 Melrose
                                 toluene).            Dr., Lenexa, KS
                                                      66214.
NADA 121-147..................  Nutra-Mix TYLAN      Ag-Mark, Inc., P.O.
                                 (tylosin             Box 127, Teachey,
                                 phosphate).          NC 28464.
NADA 122-522..................  TYLAN Sulfa-G        Custom Feed
                                 (tylosin phosphate   Blenders Corp.,
                                 and                  540 Hawkeye Ave.,
                                 sulfamethazine).     Fort Dodge, IA
                                                      50501.
NADA 124-391..................  Nutra-Mix TYLAN-     Ag-Mark, Inc., P.O.
                                 Sulfa Premixes       Box 127, Teachey,
                                 (tylosin phosphate   NC 28464.
                                 and
                                 sulfamethazine).
NADA 127-195..................  TYLAN 10 (tylosin    I.M.S. Inc., 13619
                                 phosphate).          Industrial Rd.,
                                                      Omaha, NE 68137.
NADA 129-415..................  Custom Ban Wormer    Custom Feed
                                 9.6 BANMINTH         Blenders Corp.,
                                 (pyrantel            540 Hawkeye Ave.,
                                 tartrate).           Fort Dodge, IA
                                                      50501.
NADA 130-092..................  ALFAVET              Vetem, S.p.A.,
                                 (alfaprostol).       Viale E. Bezzi 24,
                                                      20146 Milano,
                                                      Italy.
NADA 141-101..................  PREEMPT              Bioscience
                                 (competitive         Division, of Milk
                                 exclusion culture).  Specialties Co.,
                                                      1902 Tennyson
                                                      Lane, Madison, WI
                                                      53704.
ANADA 200-187.................  Isoflurane, USP....  Marsam
                                                      Pharmaceuticals,
                                                      LLC, Bldg. 31, 24
                                                      Olney Ave., Cherry
                                                      Hill, NJ 08034.
------------------------------------------------------------------------

    The Director, Center for Veterinary Medicine, under section 
512(e)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360b(e)(2)(A)), and under authority delegated by the Commissioner, 
finds that the holders of the applications listed in this document have 
repeatedly failed to submit reports required by Sec.  514.80. In 
addition, under Sec.  514.200(b), we find that the holders of the 
applications have waived any contentions concerning the legal status of 
the drug products. Therefore, under these findings, approval of the 
applications listed in this document, and all amendments and 
supplements thereto, is hereby withdrawn, effective March 18, 2013.

[[Page 14804]]

    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 applications.

    Dated: February 27, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-04998 Filed 3-6-13; 8:45 am]
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