Document ID: FDA-2012-N-0262-0001
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of Part of New Animal Drug Applications: Tiamulin
Posted Date: 2012-04-17T04:00Z

[Federal Register Volume 77, Number 74 (Tuesday, April 17, 2012)]
[Notices]
[Page 22789]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9195]

[[Page 22789]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0262]

Withdrawal of Approval of Part of a New Animal Drug Application; 
Tiamulin

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of those parts of a new animal drug application (NADA) for a tiamulin 
Type A medicated article that pertain to the production indications for 
use of increased rate of weight gain and improved feed efficiency in 
swine. This action is being taken at the sponsor's request because this 
product is no longer marketed for these uses.

DATES: Withdrawal of approval is effective April 17, 2012.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc. (Novartis), 
3200 Northline Ave., suite 300, Greensboro, NC 27408, has requested 
that FDA withdraw approval of those parts of NADA 139-472 for DENAGARD 
(tiamulin) Type A medicated article pertaining to the production 
indications for use of increased rate of weight gain and improved feed 
efficiency in swine. Novartis requested voluntary withdrawal of 
approval of these indications for use because this product is no longer 
marketed for these uses. Revised product labeling reflecting the 
withdrawal of these indications has been approved in a supplement to 
NADA 139-472.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Director of 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 those parts of NADA 139-472 pertaining to the production indications 
for use of increased rate of weight gain and improved feed efficiency 
in swine are hereby withdrawn, effective April 17, 2012.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the withdrawal of approval of 
those parts of NADA 139-472.

    Dated: March 21, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-9195 Filed 4-16-12; 8:45 am]
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