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Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone

---
identifier: "/us/fr/2013-27916"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone"
title_number: 0
title_name: "Federal Register"
section_number: "2013-27916"
section_name: "Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone"
positive_law: false
currency: "2013-11-22"
last_updated: "2013-11-22"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2013-27916"
document_type: "notice"
publication_date: "2013-11-22"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "78 FR 70062"
fr_volume: 78
docket_ids:
  - "Docket No. FDA-2013-N-0002"
effective_date: "2013-12-02"
fr_action: "Notice."
---

#  Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) for roxarsone or carbarsone Type A medicated articles at the sponsor's request because the products are no longer manufactured or marketed.

**DATES:**

Withdrawal of approval is effective December 2, 2013.

**FOR FURTHER INFORMATION CONTACT:**

John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079, *[email protected].*

**SUPPLEMENTARY INFORMATION:**

Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007, has requested that FDA withdraw approval of the following three NADAs because the products, used to manufacture Type B and Type C medicated feeds, are no longer manufactured or marketed: NADA 007-891 for 3-NITRO (roxarsone) Type A medicated article, NADA 092-953 for Roxarsone Type A Medicated Articles, and NADA 010-285 for CARB-O-SEP (carbarsone) Type A medicated article.

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is given that approval of NADAs 007-891, 092-953, and 010-285, and all supplements and amendments thereto, is hereby withdrawn.

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: November 18, 2013.

Bernadette Dunham,

Director, Center for Veterinary Medicine.