2013 NME Summary Report (Charts)

The charts below are pulled from the 2013 Novel New Drug Summary Report.
View full report: 2013 Novel New Drugs Summary (PDF - 3MB) 


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   - Receipts that received a “Refuse to File” (RTF) or “Withdrawn before filing” (WF) identifier are excluded.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







Page Last Updated: 01/31/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English