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U.S. Department of Health and Human Services

About FDA

Number of NDA and BLA efficacy supplements submitted

Dictionary: Efficacy Supplements to NDAs and BLAs are applications to make certain changes (e.g., add a new indication) to an approved marketing application. These supplements have legislatively mandated timelines for review.

Information is current as of March 31, 2015.

Fiscal Year - 2013

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Oct 2012N/A2
Nov 2012N/A15
Dec 2012N/A18
Jan 2013N/A7
Feb 2013N/A16
Mar 2013N/A4
Apr 2013N/A11
May 2013N/A11
Jun 2013N/A12
Jul 2013N/A3
Aug 2013N/A15
Sep 2013N/A8

FY 2013 Total: 122


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


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.