First Cycle Filings PDUFA FY 2005
The vertical stacked column graph presents first cycle filing review notifications for NDAs, BLAs, and efficacy supplements for FY 2003 through FY 2005. The scale is in increments of 50 with a ceiling of 300. There were no performance goals for FY 2001 and FY 2002 for first cycle filings for NDAs, BLAs, and efficacy supplements, and numbers were not reported for these fiscal years. The number of NDAs ranged from just over 100 in FY 2003, to just over 120 in FY 2004, then back to approximately 100 in FY 2005. The number of BLAs remained fairly constant over the three-year period at just under 10. The number of efficacy supplements mirrored the trend in NDAs and ranged from just over 120 in FY 2002, to just under 150 in FY 2004, then back to approximately 120 in FY 2005.