Document ID: FDA-2013-N-0002-0022
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin
Posted Date: 2013-08-23T04:00Z

[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Notices]
[Pages 52535-52536]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20615]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0002]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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: david.alterman@fda.hhs.gov.

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 Sec.  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

[[Page 52536]]

amendments thereto, is hereby withdrawn.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.
[FR Doc. 2013-20615 Filed 8-22-13; 8:45 am]
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