1988 NCE approvals
Executive Summary
The average approval time for the four "A" drugs, those signifying an important therapeutic gain, that were approved during 1988 is 17.8 months based on the June 1986 submission date for Miles' Nimotop NDA. The Jan. 9 issue of "The Pink Sheet" p. 5 incorrectly stated that the average approval time for the four "A" drugs was 15 months.