Document ID: FDA-2013-N-0002-0040
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid
Posted Date: 2013-11-26T05:00Z

[Federal Register Volume 78, Number 228 (Tuesday, November 26, 2013)]
[Notices]
[Page 70566]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28255]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Withdrawal of Approval of New Animal Drug Applications; Arsanilic 
Acid

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA) for an arsanilic acid Type A 
medicated article at the sponsor's request because the product is no 
longer manufactured or marketed.

DATES: Withdrawal of approval is effective December 6, 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, john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Fleming Laboratories, Inc., P.O. Box 34384, 
Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 
008-019 for PRO-GEN (arsanilic acid) Type A medicated article because 
the product, used to manufacture Type B and Type C medicated feeds, is 
no longer manufactured or marketed.
    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 NADA 
008-019, 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withdrawn.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 this application.

    Dated: November 20, 2013.
Bernadette Dunahm,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-28255 Filed 11-25-13; 8:45 am]
BILLING CODE 4160-01-P