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Percentage of administrative ANADAs (ANADAs submitted after all scientific decisions have been made in the JINAD process) completed on time

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. Administrative ANADAs are submitted after all scientific decisions have been made in the JINAD process.

Note: October 1, 2008 is the effective date of the AGDUFA.

Information is current as of November 30, 2012.

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• FY 2012
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Footnotes

• This metric is also an Animal Generic Drug User Fee Program performance goal. In the yearly performance report to Congress, performance is reported for a defined fiscal year receipt cohort. The methodology for reporting by fiscal year receipt cohort calculates performance statistics for submissions for the fiscal year FDA received them, regardless of when FDA ultimately acted on or approved the submissions. The data reported here is the measurement of the number of applications reviewed in a given month regardless of the cohort year.

Number of administrative ANADAs completed on time

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	0
Nov 2011	N/A	0
Dec 2011	N/A	0
Jan 2012	N/A	0
Feb 2012	N/A	0
Mar 2012	N/A	0
Apr 2012	N/A	0
May 2012	N/A	0
Jun 2012	N/A	0
Jul 2012	N/A	0
Aug 2012	N/A	0
Sep 2012	N/A	0

FY 2012 Total: 0

Number of administrative ANADAs completed within the month

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	0
Nov 2011	N/A	0
Dec 2011	N/A	0
Jan 2012	N/A	0
Feb 2012	N/A	0
Mar 2012	N/A	0
Apr 2012	N/A	0
May 2012	N/A	0
Jun 2012	N/A	0
Jul 2012	N/A	0
Aug 2012	N/A	0
Sep 2012	N/A	0

FY 2012 Total: 0