Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin

---
identifier: "/us/fr/2013-20615"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin"
title_number: 0
title_name: "Federal Register"
section_number: "2013-20615"
section_name: "Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin"
positive_law: false
currency: "2013-08-23"
last_updated: "2013-08-23"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2013-20615"
document_type: "notice"
publication_date: "2013-08-23"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "78 FR 52535"
fr_volume: 78
docket_ids:
  - "Docket No. FDA-2013-N-0002"
effective_date: "2013-09-03"
fr_action: "Notice."
---


#  Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA) is withdrawing approval of four new animal drug applications (NADAs) held by Quali-Tech Products, Inc., at the sponsor's request because the products are no longer manufactured or marketed.

**DATES:**

Withdrawal of approval is effective September 3, 2013.

**FOR FURTHER INFORMATION CONTACT:**

David Alterman, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855; 240-453-6843; email: *[email protected].*

**SUPPLEMENTARY INFORMATION:**

Quali-Tech Products, Inc., has requested that FDA withdraw approval of the following four NADAs because the products, used to manufacture Type C medicated feeds, are no longer manufactured or marketed: NADA 097-980 for Quali-Tech TYLAN-10 (tylosin phosphate) Premix, NADA 118-815 for Q.T. BAN-TECH (pyrantel tartrate), NADA 132-705 for FLAVOMYCIN (bambermycins), and NADA 133-335 for STAFAC (virginiamycin) Swine Pak 10.

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 097-980, 118-815, 132-705, and 133-335, 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: August 20, 2013.

Bernadette Dunham,

Director, Center for Veterinary Medicine.