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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 - 2013

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TimeTargetNumber
Oct 2012N/A4
Nov 2012N/A2
Dec 2012N/A5
Jan 2013N/A1
Feb 2013N/A1
Mar 2013N/A1
Apr 2013N/A5
May 2013N/A4
Jun 2013N/A3
Jul 2013N/A1
Aug 2013N/A2
Sep 2013N/A7

FY 2013 Total: 36

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 - 2013

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TimeTargetNumber
Oct 2012N/A3
Nov 2012N/A2
Dec 2012N/A8
Jan 2013N/A2
Feb 2013N/A3
Mar 2013N/A4
Apr 2013N/A0
May 2013N/A4
Jun 2013N/A0
Jul 2013N/A2
Aug 2013N/A1
Sep 2013N/A1

FY 2013 Total: 30

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

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A3
Nov 2012N/A2
Dec 2012N/A6
Jan 2013N/A1
Feb 2013N/A3
Mar 2013N/A3
Apr 2013N/A0
May 2013N/A4
Jun 2013N/A0
Jul 2013N/A2
Aug 2013N/A1
Sep 2013N/A1

FY 2013 Total: 26

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.