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- Receipts that received a “Refuse to File” (RTF) or “Withdrawn before filing” (WF) identifier are excluded.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