2013 New Molecular Enterties Summary Report (Charts) - FDA

Print 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) 

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* - 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   - Receipts that received a “Refuse to File” (RTF) or “Withdrawn before filing” (WF) identifier are excluded.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.

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