All NDA-BLA Approvals PDUFA FY 2007
The horizontal line graph presents trend lines to indicate the percent of NDAs and BLAs approved corresponding to fiscal year of receipt, or cohort, from FY 1997 to FY 2005. NDAs and BLAs are shown as a combined number. The vertical scale presents the percent of NDAs and BLAs approved and is in increments of 20 with a range from 0 to 100 percent. The horizontal scale presents the time since submission in 12-month increments with a range from 12 to 120 months. The graph shows that for FY 1997 through FY 2005 all but one cohort reached the 60 percent approval level or higher after 24 months. The only cohort below 60 percent was FY 2001 which had 49 percent of submissions approved at 60 months. The graph shows that the rate of approvals diminishes after the first 24 months and generally levels off after 60 months with most cohorts eventually reaching just above or just below an 80 percent approval rate.