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

---
identifier: "/us/fr/2020-15761"
source: "fr"
legal_status: "authoritative_unofficial"
title: "New Animal Drugs; Withdrawal of Approval of Abbreviated New Animal Drug Application"
title_number: 0
title_name: "Federal Register"
section_number: "2020-15761"
section_name: "New Animal Drugs; Withdrawal of Approval of Abbreviated New Animal Drug Application"
positive_law: false
currency: "2020-07-28"
last_updated: "2020-07-28"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2020-15761"
document_type: "rule"
publication_date: "2020-07-28"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 520"
fr_citation: "85 FR 45311"
fr_volume: 85
docket_ids:
  - "Docket No. FDA-2020-N-0002"
effective_date: "2020-07-28"
fr_action: "Notification of withdrawal."
---


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

**DATES:**

Withdrawal of approval is effective July 28, 2020.

**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:**

Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118, has requested that FDA withdraw approval of ANADA 200-323 for use of a 1-gram bolus of phenylbutazone in horses 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(21 CFR 514.116), notice is given that approval of ANADA 200-323, and all supplements and amendments thereto, is hereby withdrawn, effective July 28, 2020.

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: July 15, 2020.

Lauren K. Roth,

Associate Commissioner for Policy.