New Animal Drugs; Withdrawal of Approval of New Animal Drug Application

---
identifier: "/us/fr/2022-03539"
source: "fr"
legal_status: "authoritative_unofficial"
title: "New Animal Drugs; Withdrawal of Approval of New Animal Drug Application"
title_number: 0
title_name: "Federal Register"
section_number: "2022-03539"
section_name: "New Animal Drugs; Withdrawal of Approval of New Animal Drug Application"
positive_law: false
currency: "2022-02-28"
last_updated: "2022-02-28"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2022-03539"
document_type: "notice"
publication_date: "2022-02-28"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "87 FR 11079"
fr_volume: 87
docket_ids:
  - "Docket No. FDA-2021-N-0002"
fr_action: "Notification of withdrawal."
---


#  New Animal Drugs; Withdrawal of Approval of 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 a new animal drug application (NADA) at the sponsor's request because the product is no longer manufactured or marketed.

**DATES:**

The approval is withdrawn as of February 28, 2022.

**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 US Inc., 2500 Innovation Way, Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 093-329 for use of a prolonged-release bolus containing sulfamethazine in cattle because the product is no longer manufactured or marketed.

Therefore, under authority delegated to the Commissioner of Food and Drugs and in accordance with § 514.116 *Notice of withdrawal of approval of application* (21 CFR 514.116), notice is given that approval of NADA 093-329, and all supplements and amendments thereto, is hereby withdrawn February 28, 2022.

Elsewhere in this issue of the *Federal Register* , FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of this application.

Dated: February 14, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.