Year |
Therapeutic Potential - Priority
Review* |
Therapeutic Potential - Standard
Review** |
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 | 0 | 17 | 9 | 0 | 23 | 5 | 8 | 0 | 0 | 45 | 62 |
| 1995 | 9 | 1 | 5 | 0 | 0 | 0 | 0 | 15 | 19 | 5 | 30 | 2 | 11 | 0 | 0 | 67 | 82 |
| 1996 | 18 | 0 | 10 | 0 | 1 | 0 | 0 | 29 | 35 | 5 | 50 | 4 | 7 | 0 | 1 | 102 | 131 |
| 1997 | 9 | 1 | 6 | 1 | 3 | 0 | 0 | 20 | 30 | 2 | 52 | 12 | 4 | 0 | 1 | 101 | 121 |
| 1998 | 16 | 0 | 9 | 0 | 0 | 0 | 0 | 25 | 14 | 0 | 46 | 4 | 0 | 0 | 1 | 65 | 90 |
*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's were tracked as efficacy supplements, not as NDAs.)
7 - Drug already marketed, but without an approved NDALast Updated on 7/29/99
FDA/Center for Drug Evaluation and Research
Page Last Updated: February 18, 2000
Originator: CDER/ORM
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