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U.S. Department of Health and Human Services

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PDUFA FY 2004 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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