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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