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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 December 31, 2013.

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A3
Aug 2012N/A3
Sep 2012N/A6

FY 2012 3 month Total: 12

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 - 2012

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TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A3
Aug 2012N/A5
Sep 2012N/A4

FY 2012 3 month Total: 12

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

Fiscal Year - 2012
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A3
Aug 2012N/A4
Sep 2012N/A4

FY 2012 3 month Total: 11

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.