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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 December 31, 2013.

Fiscal Year - 2014

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TimeTargetPercent
Oct 201390100
Nov 201390100
Dec 201390100
Jan 201490TBD
Feb 201490TBD
Mar 201490TBD
Apr 201490TBD
May 201490TBD
Jun 201490TBD
Jul 201490TBD
Aug 201490TBD
Sep 201490TBD

FY 2014 YTD: 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 - 2014
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TimeTargetNumber
Oct 2013N/A1
Nov 2013N/A6
Dec 2013N/A1
Jan 2014N/ATBD
Feb 2014N/ATBD
Mar 2014N/ATBD
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 8

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

Fiscal Year - 2014
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2013N/A1
Nov 2013N/A6
Dec 2013N/A1
Jan 2014N/ATBD
Feb 2014N/ATBD
Mar 2014N/ATBD
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 8

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.