Document ID: FDA-2016-N-0002-0028
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of Part of a New Animal Drug Application;
Chlortetracycline, Procaine Penicillin, and Sulfamethazine
Posted Date: 2016-09-14T04:00Z

[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Notices]
[Page 63191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21984]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0002]

Withdrawal of Approval of Part of a New Animal Drug Application; 
Chlortetracycline, Procaine Penicillin, and Sulfamethazine

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal of approval.

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

DATES: Withdrawal of approval is effective September 14, 2016.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-0817, 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pharmgate LLC (Pharmgate), 1015 Ashes Dr., 
Suite 102, Wilmington, NC 28405 has requested that FDA withdraw 
approval of those parts of NADA 138-934 for PENNCHLOR SP 500 
(chlortetracycline, procaine penicillin, and sulfamethazine) Type A 
medicated article that pertain to use of the procaine penicillin 
component for the production indications of growth promotion and 
increased feed efficiency in swine. Pharmgate requested voluntary 
withdrawal of approval of these indications for use because PENNCHLOR 
SP 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 Sec.  514.116 Notice of withdrawal of 
approval of application (21 CFR 514.116), notice is given that approval 
of those parts of NADA 138-934 that pertain to use of procaine 
penicillin for the production indications of growth promotion and 
increased feed efficiency in swine are hereby withdrawn, effective 
September 14, 2016.
    NADA 138-934 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 138-934.

    Dated: September 6, 2016.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-21984 Filed 9-13-16; 8:45 am]
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