• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

Number of New Molecular Entity (NME) NDAs and new BLAs submitted

Dictionary: New Molecular Entity (NME) refers to a NDA with an active moiety, and new BLA refers to a BLA with an active biologic , that has not been previously approved or legally marketed in the US in any drug  or biologic product, either as a single ingredient or as part of a combination.

Information is current as of September 30, 2014.

Fiscal Year - 2014

Skip graphic and jump to text data

TimeTargetNumber
Oct 2013N/A6
Nov 2013N/A2
Dec 2013N/A3
Jan 2014N/A4
Feb 2014N/A3
Mar 2014N/A2
Apr 2014N/A4
May 2014N/A3
Jun 2014N/A0
Jul 2014N/A5
Aug 2014N/A4
Sep 2014N/A3

FY 2014 Total: 39

Footnotes

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

Number of New Molecular Entity (NME) NDAs and new BLAs approved

Fiscal Year - 2014

Skip graphic and jump to text data

TimeTargetNumber
Oct 2013N/A5
Nov 2013N/A5
Dec 2013N/A2
Jan 2014N/A2
Feb 2014N/A2
Mar 2014N/A4
Apr 2014N/A4
May 2014N/A3
Jun 2014N/A3
Jul 2014N/A4
Aug 2014N/A5
Sep 2014N/A3

FY 2014 Total: 42

Number of New Molecular Entity (NME) NDAs and new BLA approved within the first cycle in the month

Fiscal Year - 2014
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2013N/A5
Nov 2013N/A4
Dec 2013N/A2
Jan 2014N/A1
Feb 2014N/A1
Mar 2014N/A4
Apr 2014N/A4
May 2014N/A3
Jun 2014N/A2
Jul 2014N/A3
Aug 2014N/A3
Sep 2014N/A3

FY 2014 Total: 35

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.