[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, [email protected].
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amendments thereto, is hereby withdrawn, effective February 3, 2020.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]
BILLING CODE 4164-01-P