Document ID: FDA-2013-N-0002-0046
Agency: fda
Document Type: Rule
Title: Withdrawal of Approval of New Animal Drug Applications; Argent
Laboratories; Formalin; Tricaine Methanesulfonate
Posted Date: 2014-01-16T05:00Z

[Federal Register Volume 79, Number 11 (Thursday, January 16, 2014)]
[Rules and Regulations]
[Pages 2786-2787]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00722]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529

[Docket No. FDA-2013-N-0002]

Withdrawal of Approval of New Animal Drug Applications; Argent 
Laboratories; Formalin; Tricaine Methanesulfonate

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 two new animal drug applications (NADAs) held by Argent 
Laboratories. Withdrawal of approval of these NADAs was at the 
sponsor's request because the products are no longer manufactured or 
marketed.

DATES: Withdrawal of approval is effective January 27, 2014.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6843, david.alterman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Argent Laboratories, 8702 152d Ave. NE., 
Redmond, WA 98052 has requested that FDA withdraw approval of the 
following two NADAs because the products are no longer manufactured or 
marketed: NADA 042-427 for FINQUEL (tricaine methanesulfonate) and NADA 
140-831 for PARACIDE-F (formalin).
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to 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 NADAs 
042-427 and 140-831, and all supplements and amendments thereto, is 
hereby withdrawn.
    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.

[[Page 2787]]

    Dated: January 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-00722 Filed 1-15-14; 8:45 am]
BILLING CODE 4160-01-P