All NDA-BLA Approvals PDUFA FY 2006
The horizontal line graph presents a trend line to indicate the percent of NDA and BLAs approved corresponding to fiscal year of receipt, or cohort, from FY 1997 to FY 2004. 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 months to 120 months. The graph shows that for FY 1997 through FY 2004 all but one cohort reached the 60 percent approval level or higher after 24 months, illustrating that most applications are approved within the first 24 months for each year of submission to FDA. The only cohort below 60 percent was FY 2001 which was close to 50 percent of submissions approved at 60 months. The graph shows that the rate of approvals slows after two years, and levels off after 60 months with most cohorts eventually reaching close to an 80 percent approval rate.