2014 Novel Drugs Summary Report (Charts)

The charts below are pulled from the 2014 Novel New Drug Summary Report.
View full report: 2014 Novel New Drugs Summary (PDF - 13MB) 


* - The 2014 filed numbers include those filed in CY 2014 plus those currently pending filing (i.e., within their 60 day filing period) in CY 2014.
   - Receipts that received a “Refuse to File” (RTF) or “Withdrawn before filing” (WF) identifier are excluded.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.
   - The filed number is not indicative of workload in the PDUFA V Program.







Page Last Updated: 01/29/2016
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