 |
CDER NDAs Approved in Calendar Years 1990-2004 by
Therapeutic Potential and Chemical Type
Year |
Therapeutic Potential - Priority
Review*
and
Chemical Type*** |
Therapeutic Potential - Standard
Review**
and
Chemical Type*** |
Total Approvals |
| 1 |
2 |
3 |
4 |
5 |
6 |
7 |
Total |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
Total |
| 1990 |
12 |
0 |
8 |
0 |
0 |
0 |
0 |
20 |
11 |
2 |
23 |
2 |
2 |
4 |
0 |
44 |
64 |
| 1991 |
14 |
0 |
5 |
0 |
0 |
0 |
0 |
19 |
16 |
1 |
15 |
2 |
10 |
0 |
0 |
44 |
63 |
| 1992 |
11 |
0 |
5 |
0 |
1 |
0 |
0 |
17 |
15 |
1 |
30 |
5 |
21 |
1 |
1 |
74 |
91 |
| 1993 |
13 |
0 |
6 |
0 |
0 |
0 |
0 |
19 |
12 |
0 |
18 |
1 |
18 |
2 |
0 |
51 |
70 |
| 1994 |
13 |
0 |
4 |
0 |
0 |
- |
0 |
17 |
9 |
0 |
23 |
5 |
8 |
- |
0 |
45 |
62 |
| 1995 |
9 |
1 |
5 |
0 |
0 |
- |
0 |
15 |
19 |
5 |
30 |
2 |
11 |
- |
0 |
67 |
82 |
| 1996 |
18 |
0 |
10 |
0 |
1 |
- |
0 |
29 |
35 |
5 |
50 |
4 |
7 |
- |
1 |
102 |
131 |
| 1997 |
9 |
1 |
6 |
1 |
3 |
- |
0 |
20 |
30 |
2 |
52 |
12 |
4 |
- |
1 |
101 |
121 |
| 1998 |
16 |
0 |
9 |
0 |
0 |
- |
0 |
25 |
14 |
0 |
46 |
4 |
0 |
- |
1 |
65 |
90 |
| 1999 |
19 |
1 |
7 |
1 |
0 |
- |
0 |
28 |
16 |
2 |
32 |
3 |
2 |
- |
0 |
55 |
83 |
| 2000 |
9 |
1 |
9 |
1 |
0 |
- |
0 |
20 |
18 |
0 |
48 |
7 |
3 |
- |
2 |
78 |
98 |
| 2001 |
7 |
1 |
1 |
0 |
1 |
- |
0 |
10 |
17 |
1 |
23 |
9 |
5 |
- |
1 |
56 |
66 |
| 2002 |
7 |
0 |
3 |
1 |
0 |
- |
0 |
11 |
10 |
2 |
44 |
5 |
6 |
- |
0 |
67 |
78 |
|
2003 |
9 |
0 |
4 |
1 |
0 |
- |
0 |
14 |
12 |
5 |
31 |
7 |
3 |
- |
0 |
58 |
72 |
|
2004 |
17 |
0 |
4 |
1 |
3 |
- |
0 |
25 |
14 |
1 |
59 |
5 |
8 |
- |
1 |
88 |
113 |
*Priority
Review - Significant improvement compared to marketed
products in the treatment, diagnosis, or prevention of a disease.
**Standard
Review - The drug appears to have therapeutic qualities
similar to those of one or more already marketed drugs.
|
***Chemical Types:
1 - New molecular entity
2 - New ester, new salt, or other noncovalent
derivative
3 - New formulation
4 - New combination
5 - New manufacturer
6 - New indication (Beginning
in 1994, Type 6 NDAs were tracked as efficacy supplements)
7 - Drug already marketed, but without an approved
NDA |
Updated through
12/31/2004
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Date created: March 22, 2005 |
|
