79 FR 11 pgs. 2786-2787 - Withdrawal of Approval of New Animal Drug Applications; Argent Laboratories; Formalin; Tricaine Methanesulfonate
Type: RULEVolume: 79Number: 11Pages: 2786 - 2787
Pages: 2786, 2787Docket number: [Docket No. FDA-2013-N-0002]
FR document: [FR Doc. 2014-00722 Filed 1-15-14; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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 § 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notice is given that approval of NADAs 042-427 and 140-831, and all supplements and amendments thereto, is hereby withdrawn.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.
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Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-00722 Filed 1-15-14; 8:45 am]
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