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U.S. Department of Health and Human Services

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PDUFA FY 2004 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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