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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, 2014.

Fiscal Year - 2015

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TimeTargetNumber
Oct 2014N/A72
Nov 2014N/A72
Dec 2014N/A72
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 Cumulative Approvals (since 2004): 72

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 - 2015

Skip graphic and jump to text data

TimeTargetNumber
Oct 2014N/A107
Nov 2014N/A108
Dec 2014N/A108
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 Cumulative Approvals (since 2004): 108

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.