[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Notices]
[Pages 14803-14804]
From the Federal Register Online via the Government Publishing 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.
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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, [email protected].
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Table 1--NADAs and ANADA for Which Approval Is Withdrawn
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Application No. Trade Name (drug) Applicant
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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.
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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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