About FDA
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 February 28, 2013.
Fiscal Year - 2012
| Time | Target | Percent |
|---|---|---|
| Oct 2011 | 90 | 100 |
| Nov 2011 | 90 | 100 |
| Dec 2011 | 90 | 100 |
| Jan 2012 | 90 | - |
| Feb 2012 | 90 | 100 |
| Mar 2012 | 90 | 100 |
| Apr 2012 | 90 | 100 |
| May 2012 | 90 | 100 |
| Jun 2012 | 90 | 100 |
| Jul 2012 | 90 | 100 |
| Aug 2012 | 90 | 100 |
| Sep 2012 | 90 | 100 |
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
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 2 |
| Nov 2011 | N/A | 1 |
| Dec 2011 | N/A | 1 |
| Jan 2012 | N/A | 0 |
| Feb 2012 | N/A | 1 |
| Mar 2012 | N/A | 2 |
| Apr 2012 | N/A | 3 |
| May 2012 | N/A | 5 |
| Jun 2012 | N/A | 1 |
| Jul 2012 | N/A | 1 |
| Aug 2012 | N/A | 2 |
| Sep 2012 | N/A | 6 |
FY 2012 Total: 25
Number of non-administrative original ANADAs and reactivations of such applications completed within the month
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 2 |
| Nov 2011 | N/A | 1 |
| Dec 2011 | N/A | 1 |
| Jan 2012 | N/A | 0 |
| Feb 2012 | N/A | 1 |
| Mar 2012 | N/A | 2 |
| Apr 2012 | N/A | 3 |
| May 2012 | N/A | 5 |
| Jun 2012 | N/A | 1 |
| Jul 2012 | N/A | 1 |
| Aug 2012 | N/A | 2 |
| Sep 2012 | N/A | 6 |
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.
