Harry A. Smith

Erratum: &&A Survey of Drug Products Removed from the Market

AbstractA survey of drug product removal from the market was conducted for the years of 1980–1984 covering 24 firms and 95 products. The questionnaires were mailed to 46 firms and covered 200 products, 152 single entities and 48 combination products. Useable responses included 71 single entities and 24 combination products. The percentages of mode of product approval for the final sample were NDA 50%; ANDA, 16%, and grandfather clause, 34%. The mean life span was 20.4 years. The primary reasons for removal of the products were economic, 65%; regulatory, 27% and other, 8%. There was a significant difference in the approval modes and a marginally significant difference for the reasons of product removal from the market for the two product types. The reason for product removal was different for products approved under the three modes of approval, but this was only marginally significant statistically. The X2 test was used for these determinations. More drug products were removed from the market than were add...

A Survey of Drug Products Removed from the Market

AbstractA survey of drug product removal from the market was conducted for the years of 1980-1984 covering 24 firms and 95 products. the questionnaires were mailed to 46 firms and covered 200 products, 152 single entities and 48 combination products. Useable responses included 71 single entities and 24 combination products. the percentages of mode of product approval for the final sample were NDA 50%; ANDA, 16%, and grandfather clause, 34%. the mean life span was 20.4 years. the primary reasons for removal of the products were economic, 65%; regulatory, 27%, and other, 8%. There was a significant difference in the approval modes and a marginally significant difference for the reasons of product removal from the market for the two product types. the reason for product removal was different for products approved under the three modes of approval, but this was only marginally significant statistically. the X2 test was used for these determinations. More drug products were removed from the market than were ad...