Number of pending pre-Animal Generic Drug User Fee Act (AGDUFA) submissions to review at the end of the month

Main

Number of pending pre-Animal Generic Drug User Fee Act (AGDUFA) submissions to review at the end of the monthA generic new animal drug is a copy of an approved new animal drug for which patents or other periods of exclusivity are near expiration. In order for a generic animal drug to be marketed in the United States, it must be the subject of an approved ANADA. Prompt evaluation of applications for generic new animal drugs enhances the cost-effectiveness and predictability of new animal drug development. The effect of reducing the backlog of generic new animal drug submissions is anticipated to increase the number of generic new animal drug applications submitted.

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2010

FY 2010 Year End: 0

Oct 2009093Nov 2009069Dec 2009054Jan 2010030Feb 2010024Mar 2010011Apr 201003May 201003Jun 201003Jul 201003Aug 201000Sep 201000

http://www.fda.gov/AboutFDA/Transparency/track/ucm203425.htmFDA-TRACK CVM Dashboard

AGDUFAAnimal Generic Drug User Fee Act