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U.S. Department of Health and Human Services

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PDUFA FY 2004 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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