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U.S. Department of Health and Human Services

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Percentage of non-administrative original ANADAs and reactivations of such applications 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. A non-administrative ANADA contains the data that fulfills the requirements for approval. Prompt approval of safe and effective generic new animal drugs will reduce animal healthcare costs and ensure adequate supplies of new animal drugs from a variety of sources. (1)

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

Information is current as of March 31, 2014.

Fiscal Year - 2010

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TimeTargetPercent
Oct 200990N/A
Nov 200990100
Dec 200990-
Jan 201090100
Feb 201090-
Mar 201090-
Apr 201090100
May 201090-
Jun 201090100
Jul 201090-
Aug 201090-
Sep 201090100

FY 2010 Overall: 100

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 non-administrative original ANADAs and reactivations of such applications completed on time

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/AN/A
Nov 2009N/A1
Dec 2009N/A0
Jan 2010N/A1
Feb 2010N/A0
Mar 2010N/A0
Apr 2010N/A1
May 2010N/A0
Jun 2010N/A2
Jul 2010N/A0
Aug 2010N/A0
Sep 2010N/A2

FY 2010 Total: 7

Number of non-administrative original ANADAs and reactivations of such applications completed within the month

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/AN/A
Nov 2009N/A1
Dec 2009N/A0
Jan 2010N/A1
Feb 2010N/A0
Mar 2010N/A0
Apr 2010N/A1
May 2010N/A0
Jun 2010N/A2
Jul 2010N/A0
Aug 2010N/A0
Sep 2010N/A2

FY 2010 Total: 7

Glossary

ANADA

Abbreviated New Animal Drug Application

AGDUFA

Animal Generic Drug User Fee Act

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.