78 FR 45 pgs. 14803-14804 - Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications
Type: NOTICEVolume: 78Number: 45Pages: 14803 - 14804
Docket number: [Docket No. FDA-2012-N-1167]
FR document: [FR Doc. 2013-04998 Filed 3-6-13; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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 § 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 § 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.
| Application No. | Trade Name (drug) | Applicant |
|---|---|---|
| NADA 009-252 | FUMIDIL B (bicyclohexylammonium fumagillin) | Mid-Continent Agrimarketing, Inc., 8833 Quivira Rd., Overland Park, KS 66214. |
| NADA 034-601 | SYNCHRO-MATE (flurogestone acetate) | G. D. Searle LLC, Pharmacia Corp., 4901 Searle Pkwy., Skokie, IL 60077. |
| NADA 039-284 | Swisher Super Broiler 300-108 (amprolium, ethopabate, bacitracin zinc, and roxarsone) | Swisher Feed Division, William Davies Co., Inc., P.O. Box 578, Danville, IL 61832. |
| NADA 040-920 | Chick Grower-Developer Fortified (amprolium) | Honeggers and Co., Inc., 201 W. Locust St., Fairbury, IL 61739. |
| NADA 094-223 | Canine Worm Caps ( n -butyl chloride) | K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214. |
| NADA 098-429 | Medic-Meal-T Premix (tylosin phosphate) | J. C. Feed Mills, 1050 Sheffield, P.O. Box 224, Waterloo, IA 50704. |
| NADA 098-639 | TYLAN Sulfa-G (tylosin phosphate and sulfamethazine) | Bioproducts, Inc., 320 Springside Dr., suite 300, Fairlawn, OH 44333-2435. |
| NADA 106-507 | TYLAN 10 (tylosin phosphate) | Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 50501. |
| NADA 110-044 | PRO-TONE Plus Pak GF T-1 (tylosin phosphate) | Peavey Co., 730 Second Ave. South, Minneapolis, MN 55402. |
| NADA 117-688 | Dichlorophene and Toluene Capsules | Texas Vitamin Co., P.O. Box 18417, 10695 Aledo St., Dallas, TX 57218. |
| NADA 120-614 | TYLAN Sulfa-G (tylosin phosphate and sulfamethazine) | Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363. |
| NADA 120-671 | Pet-Worm-Caps (dichlorophene and toluene) | K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214. |
| NADA 121-147 | Nutra-Mix TYLAN (tylosin phosphate) | Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464. |
| NADA 122-522 | TYLAN Sulfa-G (tylosin phosphate and sulfamethazine) | Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 50501. |
| NADA 124-391 | Nutra-Mix TYLAN-Sulfa Premixes (tylosin phosphate and sulfamethazine) | Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464. |
| NADA 127-195 | TYLAN 10 (tylosin phosphate) | I.M.S. Inc., 13619 Industrial Rd., Omaha, NE 68137. |
| NADA 129-415 | Custom Ban Wormer 9.6 BANMINTH (pyrantel tartrate) | Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 50501. |
| NADA 130-092 | ALFAVET (alfaprostol) | Vetem, S.p.A., Viale E. Bezzi 24, 20146 Milano, Italy. |
| NADA 141-101 | PREEMPT (competitive exclusion culture) | Bioscience Division, of Milk 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 § 514.80. In addition, under § 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.
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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