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 CDER FIRST ACTION PERFORMANCE FOR ORIGINAL NDAs
Data as of FY 2005 Close-Out Cohort

CDER

 

  

NO.
SUBMITTED

  

RF
or WF

  

UN

  

NO.
FILED

 NUMBER OF FIRST ACTIONS
WITHIN GOAL		 PDUFA
GOALS

NUMBER OF FIRST ACTIONS
OVERDUE
          AP AE NA WD TOTAL   AP AE NA WD TOTAL
                  NO. PERCENT           NO. PERCENT
FY93
as of 9/30/96		 116 29 3 84 13 17 21 4 55 65% no goal 11 10 4 4 29 35%
 
FY94
as of 3/31/97		 127 19 16 92 20 26 36 5 87 95% 55% 0 2 3 0 5 5%
 
FY95
as of 3/31/97		 140 6 23 111 37 42 27 3 109 98% 70% 0 2 0 0 2 2%
 
FY96
as of 2/28/98		 123 5 9 109 50 38 20 1 109 100% 80% 0 0 0 0 0 0%
                                 
 
FY97
as of 11/30/98		 P 26 0 0 26 11 8 4 3 26 100% 90% 0 0 0 0 0 0%
S 102 2 5 95 44 28 19 4 95 100% 90% 0 0 0 0 0 0%
Total 128 2 5 121 55 36 23 7 121 100% 90% 0 0 0 0 0 0%
   
FY98
as of 01/31/00		 P 32 2 0 30 15 11 2 2 30 100% 90% 0 0 0 0 0 0%
S 100 6 10 84 26 28 29 1 84 100% 90% 0 0 0 0 0 0%
Total 132 8 10 114 41 39 31 3 114 100% 90% 0 0 0 0 0 0%
   

FY99
as of 12/31/00

 P 32 1 0 31 19 9 3 0 31 100% 90% 0 0 0 0 0 0%
S 104 5 4 95 23 27 7 6 63 66% 30% in 10 mos.*            
38 34 15 8 95 100% 90% in 12 mos. 0 0 0 0 0 0%
Total 136 6 4 126                          
                             

FY00
as of 10/31/01

 P 31 1 1 29 15 9 3 1 28 97% 90% 0 1 0 0 1 3%
S 102 6 4 92 25 30 9 9 73 79% 50% in 10 mos.*            
30 37 13 9 89 97% 90% in 12 mos. 1 1 1 0 3 3%
Total 133 7 5 121                          
                             

FY01
as of 09/30/02

 P 10 0 0 10 2 6 1 1 10 100% 90% 0 0 0 0 0 0%
S 92 4 2 86 12 38 20 7 77 90% 70% in 10 mos.*            
16 40 21 7 84 98% 90% in 12 mos. 1** 0 1** 0 2 2%
Total 102 4 2 96                          
                             

FY02
as of 02/29/04

 P 12 0 0 12 7 3 2 0 12 100% 90% in  6 mos. 0 0 0 0 0 0%
S 95 7 4 84 31 42 9 1 83 99% 90% in 10 mos. 0 1 0 0 1 1%
Total 107 7 4 96                          
                             

FY03
as of 10/31/04

 P 24 1 4 19 9 8 1 1 19 100% 90% in  6 mos. 0 0 0 0 0 0%
S 92 3 7 82 28 43 8 3 82 100% 90% in 10 mos. 0 0 0 0 0 0%
Total 116 4 11 101                          
                             

FY04
as of 8/31/06

 P 30 2 2 26 13 8 2 2 25 96% 90% in  6 mos. 1 0 0 0 1 4%
S 102 2 6 94 41 34 13 3 91 97% 90% in 10 mos. 3 0 0 0 3 3%
Total 132 4 8 120                          
                             

FY05
as of 10/31/06

 P 30 1 0 29 15 8 1 1 25 86% 90% in  6 mos. 1 0 3 0 4 14%
S 89 9 7 73 27 29 15 1 72 99% 90% in 10 mos. 0 0 1 0 1 1%
Total 119 10 7 102                          
*The Standard NDA 10-month goal and performance figures are a subset of the 12-month goal and performance figures. These NDAs are only considered overdue when they exceed the 12-month goal.

**Two applications met the 10-month goal with an extension, but did not meet the 12-month goal (with no extension).

Abbreviations:

AP             Approved
AE             Approvable
NA            Not approvable
WD            Withdrawn   
RF             Refuse to file
WF            Withdrawn from filing
UN            Unacceptable for filing because user fee not received


P -   Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.

S -   Standard Review - The drug appears to have therapeutic qualities similar to those of one or more already marketed drugs.

 

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Date created: November 14, 2006; Updated January 17, 2007

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