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U.S. Department of Health and Human Services

Drugs

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NDA Approvals 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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