Document ID: FDA-2014-N-0002-0026
Agency: fda
Document Type: Rule
Title: Withdrawal of Approval of Part of a New Animal Drug Application; Procaine Penicillin
Posted Date: 2014-07-02T04:00Z

[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Rules and Regulations]
[Pages 37621-37622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15273]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2014-N-0002]

Withdrawal of Approval of Part of a New Animal Drug Application; 
Procaine Penicillin

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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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 three-way, 
fixed-ratio, combination drug Type A medicated article that pertain to 
use of the procaine penicillin component for growth promotion 
indications in swine. This action is being taken at the sponsor's 
request because the three-way Type A medicated article is no longer 
manufactured.

DATES: Withdrawal of approval is effective July 2, 2014.

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: Zoetis Inc. (Zoetis), 333 Portage St., 
Kalamazoo, MI 49007 has requested that FDA withdraw approval of those 
parts of NADA 035-688 for AUREOMIX Granular 500 (chlortetracycline, 
procaine penicillin, and sulfamethazine) Type A medicated article that 
pertain to use of the procaine penicillin component for growth

[[Page 37622]]

promotion indications in swine. Zoetis requested voluntary withdrawal 
of approval of these indications for use because AUREOMIX Granular 500 
Type A medicated article is no longer manufactured.
    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 21 CFR 514.116 Notice of withdrawal of 
approval of application, notice is given that approval of those parts 
of NADA 035-688 that pertain to use of procaine penicillin for the 
production indications of growth promotion and increased feed 
efficiency in swine are hereby withdrawn, effective July 2, 2014.
    NADA 035-688 was identified as being affected by guidance for 
industry (GFI) 213, ``New Animal Drugs and New Animal Drug 
Combination Products Administered in or on Medicated Feed or Drinking 
Water of Food-Producing Animals: Recommendations for Drug Sponsors for 
Voluntarily Aligning Product Use Conditions With GFI 209'', 
December 2013.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the withdrawal of approval of 
these parts of NADA 035-688.

    Dated: June 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-15273 Filed 6-30-14; 11:15 am]
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