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

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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.

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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.

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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notice is given that approval of NADAs 042-427 and 140-831, and all supplements and amendments thereto, is hereby withdrawn.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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Dated: January 9, 2014.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. 2014-00722 Filed 1-15-14; 8:45 am]

BILLING CODE 4160-01-P