|
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.
|
Back
to Top
Reports
Date created: November 14, 2006; Updated January 17, 2007
|
|