Long Descriptions

PDUFA FY 2004 PERFORMANCE REPORT -- GRAPH DESCRIPTIONS

Applications Submitted and Filed

The total number of submitted and filed priority and standard applications filed was 125 in FY 1995 and dropped to 120 in FY 1996. The total number of applications increased to 133 in FY 1997 representing 28 priority and 105 standard applications. The total number of applications dropped to 121 in FY 1998 representing 38 priority and 83 standard applications. The total number of applications increased to 127 in FY 1999 representing 31 priority and 96 standard applications. The total number of applications increased again to 134 in FY 2000 representing 33 priority and 101 standard applications. The total number of applications dropped to 104 in FY 2001 representing 13 priority and 91 standard applications. The total number of applications slightly increased to 105 in FY 2002 representing 15 priority and 90 standard applications. The total number of applications slightly increased again to 109 in FY 2003 representing 23 priority and 86 standard applications. The total number of applications significantly increased to 137 in FY 2004 representing 25 priority and 112 standard applications.

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Median Approval Times

The median approval time for NDA and BLA original priority applications was 12.2 months and 21.6 months for standard applications in FY 1994. The median approval time for priority applications dropped to 11.8 months and 15.8 months for standard applications in FY 1995. The median approval time for priority applications dropped again to 8.2 months and 14.7 months for standard applications in FY 1996. The median approval time for priority applications dropped yet again to 7.8 months and 12.5 months for standard applications in FY 1997. The median approval time for priority applications experienced another drop to 6.0 months and an increase of 17.9 months for standard applications in FY 1998. The median approval time for priority applications remained at 6.0 months and dropped to 12.0 months for standard applications in FY 1999. The median approval time for priority applications remained again at 6.0 months and increased to 13.9 months for standard applications in FY 2000. The median approval time for priority applications significantly increased to 15.6 months and 22.1 months for standard applications in FY 2001. The median approval time for priority applications significantly dropped to 9.0 months and 12.8 months for standard applications in FY 2002. The median approval time for priority applications is estimated to drop again to 6.4 months and estimated to increase to 13.8 months for standard applications for FY 2003.

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Percent of Filed NDAs and BLAs Approved on First Review Cycle

The percentage of priority applications approved on the first cycle was 46% and 45% for standard applications in FY 1997. The percentage of priority applications approved on the first cycle increased to 50% and dropped to 29% for standard applications in FY 1998. The percentage of priority applications approved on the first cycle increased again to 58% and increased to 39% for standard applications in FY 1999. The percentage of priority applications approved on the first cycle dropped to 45% and 31% for standard applications in FY 2000. The percentage of priority applications approved on the first cycle significantly dropped to 15% and 19% for standard applications in FY 2001. The percentage of priority applications approved on the first cycle significantly increased to 47% and 36% for standard applications in FY 2002. The percentage of priority applications approved on the first cycle increased again to 57% and dropped slightly to 35% for standard applications in FY 2003.

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Original Applications Filed

The total number of original applications filed was 134 in FY 2000 representing 121 NDAs and 13 BLAs. The total number of original applications dropped to 104 in FY 2001 representing 96 NDAs and 8 BLAs. The total number of original applications slightly increased to 105 in FY 2002 representing 96 NDAs and 9 BLAs. The total number of original applications increased again to 109 in FY 2003 representing 101 NDAs and 8 BLAs. The total number of original applications significantly increased to 137 in FY 2004 representing 128 NDAs and 9 BLAs, a five-year high for NDAs.

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Resubmitted Applications

The total number of resubmitted applications filed was 89 in FY 2000 representing 80 NDAs and 9 BLAs. The total number of resubmitted applications dropped to 78 in FY 2001 representing 62 NDAs and 16 BLAs. The total number of resubmitted applications slightly dropped to 77 in FY 2002 representing 62 NDAs and 15 BLAs. The total number of resubmitted applications slightly dropped again to 74 in FY 2003 representing 62 NDAs and 12 BLAs. The total number of resubmitted applications increased to 81 in FY 2004 representing 79 NDAs and 2 BLAs.

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Efficacy Supplements Filed

The total number of efficacy supplements filed was 187 in FY 2000 representing 175 NDAs and 12 BLAs. The total number of efficacy supplements dropped to 170 in FY 2001 representing 154 NDAs and 16 BLAs. The total number of efficacy supplements remained at 170 in FY 2002 representing 159 NDAs and 11 BLAs. The total number of efficacy supplements dropped to 153 in FY 2003 representing 138 NDAs and 15 BLAs. The total number of efficacy supplements significantly increased to 184 in FY 2004 representing 165 NDAs and 19 BLAs.

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Resubmitted Efficacy Supplements

The total number of resubmitted efficacy supplements received was 59 in FY 2003 representing 56 NDAs and 3 BLAs. The total number of resubmitted efficacy supplements slightly dropped to 57 in FY 2004 representing 54 NDAs and 3 BLAs.

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Manufacturing Supplements Filed

The total number of manufacturing supplements filed was 2,025 in FY 2000 representing 1,438 NDAs and 587 BLAs. The total number of manufacturing supplements increased to 2,065 in FY 2001 representing 1,474 NDAs and 591 BLAs. The total number of manufacturing supplements significantly increased to 2,476 in FY 2002 representing 1,759 NDAs and 717 BLAs. The total number of manufacturing supplements increased again to 2,598 in FY 2003 representing 1,696 NDAs and 902 BLAs. The total number of manufacturing supplements dropped to 2,481 in FY 2004 representing 1,616 NDAs and 865 BLAs.

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First Cycle Filings

The total number of first cycle filings was 233 in FY 2003 representing 104 NDAs, 8 BLAs, and 121 efficacy supplements. The total number of first cycle filings significantly increased to 267 in FY 2004 representing 130 NDAs, 7 BLAs, and 130 efficacy supplements.

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Reviewable Unit Submissions

There were 13 NDA reviewable unit submissions and 1 BLA reviewable unit submission in FY 2004.

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