First Cycle Filings for Original NDAs, BLAs, and Efficacy Supplements PDUFA FY 2006
The vertical stacked column graph presents first cycle filing review notifications for NDAs, BLAs, and efficacy supplements for FY 2003 through FY 2006. The scale is in increments of 50 with a range from 0 to 300. There was no performance goal for FY 2002 for first cycle filings for NDAs, BLAs, and efficacy supplements, and numbers were not reported for this year. The number of NDAs ranged from slightly over 100 in FY 2003, to just over 120 in FY 2004, then fell to just over 100 in FY 2005. At the end of FY 2006, the number grew to slightly more than the FY 2003 level. The number of BLAs remained fairly constant over the first 3 years at just under 10, and increased to 13 by the end of FY 2006. The number of efficacy supplements mirrored the trend in NDAs with just over 120 in FY 2003, to just under 150 in FY 2004, then fell to approximately the FY 2003 level in FY 2005, before increasing to 140 in FY 2006. It is footnoted that the First Cycle Filing Review goal applies to original NDAs, BLAs, and efficacy supplements only. It does not apply to NDA labeling supplements containing clinical data, even though these are counted as efficacy supplements for other PDUFA performance purposes. Therefore, the number of filing review notifications for efficacy supplements is less than the total number of efficacy supplements filed (as shown on page 14).