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Table 2 FDA Orphan Drug Designations and Approvals. U.S. 1983–2007

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

Number of Designations

Number of Sponsors

Orphan Designations

Orphan Designations per Sponsor

NDA Approvals

NDA Approvals per Sponsor

NDA Approvals per Designation

NME Approvals

NME Approvals per Sponsor

NME Approvals per Designation

1

509

509

1.0

48

0.09

0.09

18

0.04

0.04

2

140

280

2.0

40

0.29

0.14

20

0.14

0.07

3

61

183

3.0

28

0.46

0.15

7

0.11

0.04

4

33

132

4.0

12

0.36

0.09

4

0.12

0.03

5

14

70

5.0

8

0.57

0.11

5

0.36

0.07

6

8

48

6.0

9

1.13

0.19

8

1.00

0.17

7

11

77

7.0

24

2.18

0.31

10

0.91

0.13

8

7

56

8.0

16

2.29

0.29

3

0.43

0.05

9

3

27

9.0

10

3.33

0.37

3

1.00

0.11

10 or more

24

411

17.1

127

5.29

0.31

37

1.54

0.09

Total

810

1,793

2.2

322

0.40

0.18

115

0.14

0.06