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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 June 30, 2014.

Fiscal Year - 2012

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TimeTargetPercent
Oct 201190100
Nov 201190100
Dec 201190100
Jan 201290-
Feb 201290100
Mar 201290100
Apr 201290100
May 201290100
Jun 201290100
Jul 201290100
Aug 201290100
Sep 201290100

FY 2012 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 - 2012
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TimeTargetNumber
Oct 2011N/A2
Nov 2011N/A1
Dec 2011N/A1
Jan 2012N/A0
Feb 2012N/A1
Mar 2012N/A2
Apr 2012N/A3
May 2012N/A5
Jun 2012N/A1
Jul 2012N/A1
Aug 2012N/A2
Sep 2012N/A6

FY 2012 Total: 25

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A2
Nov 2011N/A1
Dec 2011N/A1
Jan 2012N/A0
Feb 2012N/A1
Mar 2012N/A2
Apr 2012N/A3
May 2012N/A5
Jun 2012N/A1
Jul 2012N/A1
Aug 2012N/A2
Sep 2012N/A6

FY 2012 Total: 25

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.