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U.S. Department of Health and Human Services

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Number of pre-Animal Generic Drug User Fee Act (AGDUFA) generic new animal drug submissions reviewed and completed during the month

Dictionary: A 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.

Fiscal Year - 2010

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Oct 2009N/A39
Nov 2009N/A24
Dec 2009N/A15
Jan 2010N/A24
Feb 2010N/A6
Mar 2010N/A13
Apr 2010N/A8
May 2010N/A0
Jun 2010N/A0
Jul 2010N/A0
Aug 2010N/A3
Sep 2010N/A0

FY 2010 Overall: 132


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.