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Home Media Center Industry news 2013 New Molecular Enterties Summary Report (Charts) - FDA

2013 New Molecular Enterties Summary Report (Charts) - FDA

10 December 2014

U.S. Food and Drug Administration

The charts below are pulled from the 2013 Novel New Drug Summary Report. 

View full report: 2013 Novel New Drugs Summary (PDF - 3MB) 

Applications Filed *NMEs ApprovedNumber of New Molecular Entities (NMEs) Approved and Applications Filed10 Calendar Year ProgressionApplications FiledNMEs Approved200420052006200720082009201020112012201301020304050010203040502005● Applications Filed: 38● NMEs Approved: 20Highcharts.com

* - The 2013 filed numbers include those filed in CY 2013 plus those currently pending filing (i.e., within their 60 day filing period) in CY 2013. 
   - Receipts that received a “Refuse to File” (RTF) or “Withdrawn before filing” (WF) identifier are excluded. 
   - Multiple submissions (multiple or split originals) pertaining to a single new molecular/biologic entity are only counted once. 
   - There is a BLA included that does not currently have a review schedule but is known to contain a new active ingredient. 
   - The filed number is not indicative of workload in the PDUFA V Program.

First-in-Class Designationof the 27 NMEs Approved in Calendar Year 2013Other (18): 67.0 %First-in-Class (9): 33.0 %Other (18)NMEs Approved: 67.0%Highcharts.com
Orphan Drug Designationof the 27 NMEs Approved in Calendar Year 2013Other (18): 67.0 %Orphan Drugs (9): 33.0 %Highcharts.com
NMEs ApprovedInnovative Methods for Expediting NMEs to Marketof the 27 NMEs Approved in Calendar Year 2013Fast Track (10 NMEs)Breakthrough (3 NMEs)Priority Review (10 NMEs)AcceleratedApproval (2 NMEs)010203040Fast Track (10 NMEs)Total: 37.0 %Highcharts.com
First Cycle Approval Designationof the 27 NMEs Approved in Calendar Year 2013Other (3): 12.0 %First Cycle Approval (24): 88.0 %Highcharts.com
First Approved in the U.S. Designationof the 27 NMEs Approved in Calendar Year 2013Other (7): 26.0 %1st Approved in U.S. (20): 74.0 %1st Approved in U.S. (20)NMEs Approved:
Highcharts.com

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