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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 September 30, 2014.

Fiscal Year - 2014

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TimeTargetNumber
Oct 2013N/A62
Nov 2013N/A62
Dec 2013N/A63
Jan 2014N/A63
Feb 2014N/A64
Mar 2014N/A66
Apr 2014N/A66
May 2014N/A66
Jun 2014N/A66
Jul 2014N/A66
Aug 2014N/A67
Sep 2014N/A70

Cumulative Approvals (since 2004): 70

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 - 2014

Skip graphic and jump to text data

TimeTargetNumber
Oct 2013N/A101
Nov 2013N/A102
Dec 2013N/A102
Jan 2014N/A103
Feb 2014N/A104
Mar 2014N/A104
Apr 2014N/A104
May 2014N/A104
Jun 2014N/A104
Jul 2014N/A104
Aug 2014N/A106
Sep 2014N/A107

Cumulative Approvals (since 2004): 107

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.