Document ID: FDA-2019-N-0002-0030
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application; Withdrawal of Approval of Abbreviated New Animal Drug Applications
Posted Date: 2020-01-24T05:00Z

[Federal Register Volume 85, Number 16 (Friday, January 24, 2020)]
[Rules and Regulations]
[Pages 4210-4211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00422]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, and 529

[Docket No. FDA-2019-N-0002]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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[[Page 4211]]

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA) and two abbreviated new animal 
drug applications (ANADAs) at the sponsors' request because the 
products are no longer manufactured or marketed.

DATES: Withdrawal of approval is applicable February 3, 2020.

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: Fleming Laboratories, Inc., P.O. Box 34384, 
Charlotte, NC 28234, has requested that FDA withdraw approval of NADA 
010-005 for use of WAZINE (dipiperazine sulfate and piperazine 
hydrochloride) Soluble Powders because the product is no longer 
manufactured or marketed.
    Also, Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, 
Peachtree Corners, GA 30092, has requested that FDA withdraw approval 
of ANADA 200-200 for use of Halothane USP (halothane) because the 
product is no longer manufactured or marketed.
    Lastly, Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 
61103, has requested that FDA withdraw approval of ANADA 200-472 for 
use of Fomepizole Injection because the product is 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 010-005 and ANADAs 200-200 and 200-472, and all supplements and 
amendments thereto, is hereby withdrawn, effective February 3, 2020.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary withdrawal of 
approval of these applications.

    Dated: January 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00422 Filed 1-23-20; 8:45 am]
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