78 FR 164 pgs. 52535-52536 - Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin
Type: NOTICEVolume: 78Number: 164Pages: 52535 - 52536
Pages: 52535, 52536Docket number: [Docket No. FDA-2013-N-0002]
FR document: [FR Doc. 2013-20615 Filed 8-22-13; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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.
[top] 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
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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