January 17, 2014

US FDA to withdraw approval of new animal drug applications

In order to reflect the withdrawal of approval of two new animal drug applications (NADAs) held by Argent Laboratories, the Food and Drug Administration (FDA) is amending the animal drug regulations which is to take effect on January 27, 2014.

Argent Laboratories 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).

Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 042-427 and 140-831, and all supplements and amendments thereto, is withdrawn. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval.

Following these withdrawals of approval, Argent Laboratories will no longer be the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for this firm.