New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application

---
identifier: "/us/fr/2016-19915"
source: "fr"
legal_status: "authoritative_unofficial"
title: "New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application"
title_number: 0
title_name: "Federal Register"
section_number: "2016-19915"
section_name: "New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application"
positive_law: false
currency: "2016-08-29"
last_updated: "2016-08-29"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2016-19915"
document_type: "rule"
publication_date: "2016-08-29"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 558"
fr_citation: "81 FR 59135"
fr_volume: 81
docket_ids:
  - "Docket No. FDA-2016-N-0002"
effective_date: "2016-09-08"
fr_action: "Notification of withdrawal."
---


#  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, *[email protected]* .

**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 |
| --- | --- | --- |
| 012-548 | TYLOSIN (tylosin phosphate)/HYGROMIX (hygromycin B) | 558.274 |
| 013-162 | TYLAN TM (tylosin phosphate) Type A medicated article | 558.625 |
| 013-388 | TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B) Premix | 558.274 |
| 015-166 | TYLAN TM (tylosin phosphate) Type A medicated article | 558.625 |
| 127-507 | 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 | TYLAN (tylosin phosphate)/COBAN (monensin) | 558.355 |
| 141-170 | TYLAN (tylosin phosphate)/MONTEBAN (narasin) | 558.363 |
| 141-198 | TYLAN TM (tylosin phosphate)/BIO-COX (salinomycin) | 558.550 |

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.