2016-19915. 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.

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, [e-mail].

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:

File No.	Product name	21 CFR section
012-548 1	TYLOSIN (tylosin phosphate)/HYGROMIX (hygromycin B)	558.274
013-162 1	TYLAN TM (tylosin phosphate) Type A medicated article	558.625
013-388 1	TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B) Premix	558.274
015-166 1	TYLAN TM (tylosin phosphate) Type A medicated article	558.625
127-507 1	TYLAN 5 SULFA-G (tylosin 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)	558.630
141-164 1	TYLAN (tylosin phosphate)/COBAN (monensin)	558.355
141-170 1	TYLAN (tylosin phosphate)/MONTEBAN (narasin)	558.363
141-198 1	TYLAN TM (tylosin phosphate)/BIO-COX (salinomycin)	558.550
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 § 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013-388, 015-166, 127-507, 141-164, 141-170, and 141-198, and all supplements and amendments thereto, is hereby withdrawn, effective September 8, 2016.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.