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First Cycle Filings for Original NDAs, BLAs, and Efficacy Supplements PDUFA FY 2007
The vertical stacked column graph presents first cycle filing review notifications for NDAs, BLAs, and efficacy supplements for FY 2003 through FY 2007. Efficacy supplements are presented in a bar for each fiscal year while NDAs and BLAs are presented together in a stacked bar for each fiscal year. The vertical scale is in increments of 50 with a range from 0 to 200. The horizontal scale is by fiscal year. The graph indicates that the number of first cycle filings for efficacy supplements alternately increased and decreased each year over the 5-year period. In FY 2003, the total first cycle filings for efficacy supplements was 121, increased to 132 in FY 2004, decreased to 124 in FY 2005, increased to 142 in FY 2006, and decreased to 138 in FY 2007. The graph also indicates that the total number of first cycle filings for NDAs and BLAs alternately increased and decreased each year, but BLA filings alone either remained the same or increased during the period. The total number of first cycle filings for NDAs and BLAs, initially at 112 in FY 2003 with 104 as NDAs and 8 as BLAs, increased to 132 in FY 2004 with 123 as NDAs and 9 as BLAs, and decreased to 111 in FY 2005 with 102 as NDAs and 9 as BLAs. In FY 2006, the total number of first cycle filings for NDAs and BLAs increased again to 123 with 111 as NDAs and 12 as BLAs and decreased to 121 in FY 2007 with 104 as NDAs and 17 as BLAs.
