New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application
Federal Register, Volume 81 Issue 167 (Monday, August 29, 2016)
Federal Register Volume 81, Number 167 (Monday, August 29, 2016)
Rules and Regulations
Pages 59135-59136
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2016-19915
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
Docket No. FDA-2016-N-0002
New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application
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 eight new animal drug applications (NADAs) at the sponsor's request because these products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective September 8, 2016.
FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 has requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:
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21 CFR
File No. Product name section
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012-548 \1\............ TYLOSIN (tylosin phosphate)/ 558.274
HYGROMIX (hygromycin B).
013-162 \1\............ TYLAN TM (tylosin phosphate) 558.625
Type A medicated article.
Page 59136
013-388 \1\............ TYLAN (tylosin phosphate)/ 558.274
HYGROMIX (hygromycin B) Premix.
015-166 \1\............ TYLAN TM (tylosin phosphate) 558.625
Type A medicated article.
127-507 \1\............ TYLAN 5 SULFA-G (tylosin 558.630
phosphate and sulfamethazine),
TYLAN 10 SULFA-G (tylosin
phosphate and sulfamethazine),
TYLAN 20 SULFA-G (tylosin
phosphate and sulfamethazine),
TYLAN 40 SULFA-G (tylosin
phosphate and sulfamethazine).
141-164 \1\............ TYLAN (tylosin phosphate)/COBAN 558.355
(monensin).
141-170 \1\............ TYLAN (tylosin phosphate)/ 558.363
MONTEBAN (narasin).
141-198 \1\............ TYLAN TM (tylosin phosphate)/ 558.550
BIO-COX (salinomycin).
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\1\ These NADAs were identified as being affected by guidance for
industry #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.
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 012-548, 013-162, 013-388, 015-166, 127-507, 141-164, 141-170, and 141-
198, and all supplements and amendments thereto, is hereby withdrawn, effective September 8, 2016.
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: August 8, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
FR Doc. 2016-19915 Filed 8-26-16; 8:45 am
BILLING CODE 4164-01-P
