Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin
Federal Register, Volume 79 Issue 69 (Thursday, April 10, 2014)
Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)
Rules and Regulations
Page 19816
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2014-08010
Page 19816
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
Docket No. FDA-2014-N-0002
Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 19 new animal drug applications (NADAs) for certain Type A medicated articles and Type B medicated feeds. This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective April 21, 2014.
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, john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The following 5 sponsors have requested that FDA withdraw approval of the 19 NADAs listed in the following tables because the products are no longer manufactured or marketed:
ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115:
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NADA Product name
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091-582 \1\....................... Gilt Edge TYLAN (tylosin phosphate)
Mix.
108-484 \1\....................... HFA Tylosin-10 Plus Sulfa (tylosin
phosphate and sulfamethazine).
110-045 \1\....................... Good Life TYLAN 10 (tylosin
phosphate) Premix.
110-439 \1\....................... HFA HYGROMIX 0.48 (hygromycin B)
Medicated Premix.
128-411 \1\....................... TYLAN 5 Sulfa (tylosin phosphate and
sulfamethazine) Premix.
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Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX 79105:
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NADA Product name
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138-187 \1\....................... TYLAN 40 or 100 (tylosin phosphate).
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Ridley USA, Inc. d/b/a Ridley Feed Ingredients, 1609 1st Ave., P.O. Box 110, Mendota, IL 61342:
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NADA Product name
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099-468 \1\....................... Waynextra for Swine (tylosin
phosphate).
131-958 \1\....................... TYLAN Sulfa-G (tylosin phosphate and
sulfamethazine).
132-136........................... Ban-A-Worm II (pyrantel tartrate).
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Provimi North America, Inc., 6531 State Rte. 503, Lewisburg, OH 45338:
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NADA Proprietary name
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103-089 \1\....................... TYLAN 5, 10, 20, or 40 (tylosin
phosphate).
118-814........................... WORM-BAN 5 or 10 (pyrantel
tartrate).
127-508 \1\....................... HYGROMIX 0.6 (hygromycin B).
131-413........................... FLAVOMYCIN 0.4 or 2 (bambermycins).
133-333 \1\....................... STAFAC 10 (virginiamycin).
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Virbac AH, Inc., 3200 Meacham Blvd., Fort Worth, TX 76137:
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NADA Proprietary name
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013-214 \1\....................... PURINA HYGROMIX (hygromycin B) for
Swine.
042-660 \1\....................... PURINA Pork-Plus (tylosin phosphate
and sulfamethazine).
043-387 \1\....................... PURINA Hog Plus II (tylosin
phosphate).
099-767 \1\....................... PURINA TYLAN 40 (tylosin) Plus
Sulfamethazine.
132-574 \1\....................... PURINA Check-R-Ton Ll (lincomycin
hydrochloride).
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\1\ The NADAs listed were identified as being affected by guidance for industry (GFI) 213, ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI 209'', December 2013.
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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 the NADAs listed in this document, and all supplements and amendments thereto, is hereby withdrawn.
Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications.
Dated: April 4, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
FR Doc. 2014-08010 Filed 4-9-14; 8:45 am
BILLING CODE 4160-01-P
