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Table 1 FDA Orphan Drug Designations, Approvals and NMEs. U.S. 1983–2007

From: Incentives for orphan drug research and development in the United States

Year Designations Approvals NMEs
1983 1 2 1
1984 40 3 2
1985 48 7 3
1986 32 6 4
1987 59 9 4
1988 73 10 4
1989 76 12 3
1990 88 12 5
1991 79 13 7
1992 56 14 6
1993 63 13 6
1994 59 11 3
1995 55 11 5
1996 58 24 8
1997 52 19 4
1998 65 20 7
1999 73 19 6
2000 69 14 2
2001 75 6 3
2002 61 14 5
2003 95 14 4
2004 131 14 10
2005 123 20 6
2006 141 22 3
2007 121 13 4
Total 1793 322 115