Document ID: FDA-2017-N-0002-0004
Agency: fda
Document Type: Notice
Title: New Animal Drugs; Withdrawal of Approval of a New Animal Drug
Application
Posted Date: 2017-07-12T04:00Z

[Federal Register Volume 82, Number 132 (Wednesday, July 12, 2017)]
[Notices]
[Pages 32188-32189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14566]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0002]

New Animal Drugs; Withdrawal of Approval of a New Animal Drug 
Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of two new animal drug applications (NADAs). This action is being taken 
at the sponsor's request because these products are no longer 
manufactured or marketed.

DATES: Withdrawal of approval is effective July 24, 2017.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Zoetis, Inc., 333 Portage St., Kalamazoo, MI 
49007 has requested that FDA withdraw approval of NADA 065-291 for bulk 
dihydrostreptomycin sulfate and NADA 065-324 for bulk streptomycin 
sulfate because the products are no longer manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs, 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 065-291 and NADA 065-324, and all supplements and amendments 
thereto, is hereby withdrawn, effective July 24, 2017.
    As neither of these NADAs was codified, the animal drug regulations 
do not require amendment to reflect the voluntary withdrawal of 
approval of these applications.

[[Page 32189]]

    Dated: July 7, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14566 Filed 7-11-17; 8:45 am]
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