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U.S. Department of Health and Human Services

About FDA

PEPFAR drugs (NDAs) cumulative approvals and tentative approvals since 2004

Dictionary: PEPFAR applications are marketing applications for single entity, fixed dose combination (FDC), and co-packaged versions of previously approved antiretroviral therapies for the treatment of AIDS. The initiative includes an expedited review process and ensures that safe, effective, and quality manufactured antiretroviral drugs are available in global areas of need.

Information is current as of December 31, 2013.

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A57
Nov 2012N/A59
Dec 2012N/A59
Jan 2013N/A59
Feb 2013N/A59
Mar 2013N/A59
Apr 2013N/A59
May 2013N/A60
Jun 2013N/A61
Jul 2013N/A61
Aug 2013N/A61
Sep 2013N/A61

FY 2013 Overall: 61

Footnotes

  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.

PEPFAR drugs (ANDAs) cumulative approvals and tentative approvals since 2004

Fiscal Year - 2013

Skip graphic and jump to text data

TimeTargetNumber
Oct 2012N/A98
Nov 2012N/A98
Dec 2012N/A98
Jan 2013N/A98
Feb 2013N/A98
Mar 2013N/A98
Apr 2013N/A99
May 2013N/A99
Jun 2013N/A99
Jul 2013N/A100
Aug 2013N/A100
Sep 2013N/A100

FY 2013 Overall: 100

Footnotes

  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.

Glossary

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.