Table 2.    Median clinical development and regulatory review times (mos.) for psychotropic and

                  all new chemical entities approved in the United States, 1963-1997.

 

IND Phase

NDA Phase

Total Phase

 

 

 

Median

(Range)

 

N

 

Median

(Range)

 

N

 

Median

(Range)

 

N
             

Antianxiety

65.9

(19.0-128.0)

9

23.8

(7.5-76.4)

9

134.8

(35.6-173.4)

9

 

 

Antidepressant

68.5

(13.7-234.0)

18

38.9

(6.4-131.7)

18

131.9

(25.0-240.5)

18

 

 

 

Antipsychotic

63.5

(17.8-189.4)

10

22.9

(8.2-135.8)

14

100.4

(28.7-214.2)

10

 

 

 

Sedative/

Hypnotic

67.8

(36.9-142.9)

9

44.6

(28.6-84.2)

9

121.7

(80.5-175.1)

9

 

 

Other NCEs

53.5

(3.5-311.4)

529

21.5

(0.6-131.4)

593

78.5

(11.8-344.6)

529

 

The IND phase is the time from IND filing to NDA submission.

The NDA phase is the time from NDA submission to NDA approval.

The total phase is the time from IND filing to NDA approval.
 
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published 2000