OBJECTIVES The pharmaceutical industry serves societal needs by bringing innovative products and therapies to market. However, innovation does not guarantee market longevity. Consequently, some products will be evaluated and considered for market discontinuation. The purpose of this study was to identify drug market discontinuations, provide reasons for discontinuation, and characterize discontinued products by application type. METHODS Data were derived from the FDA databases “Approved Drug Products” and the "Approved Drug Products with Therapeutic Equivalence Evaluations," Federal Register, and Medline. Market discontinuations were classified by approval types (New Drug Application -NDA and Abbreviated New Drug Application-ANDA) and by reasons for discontinuation (safety, efficacy and financial reasons). Biological licenses and tentative approvals were excluded from analysis. Results were obtained using descriptive statistics and chi-squared tests. RESULTS FDA databases contained a total of 2093 drug product and combination approvals between February 1939 and December 2008. Of those products, 42.3% had generic competition. A total of 595 (28.4%) drug products were discontinued during the study period. Discontinued products included 37.2% of the brand products and 15.6% of the generic products (p<0.001). Safety was the reason for discontinuation for 59 drug products, which represented 2.8% of the approved drugs and accounted for 9.9 % of the product discontinuations. Databases contained 23,931 approvals, including 8,174 NDAs and 15,757 ANDAs. Discontinued applications accounted for 42.3% of all applications, and included 43.9% of the NDAs and 41.8% of the ANDAs approved during the study period. CONCLUSIONS One-third of the drugs approved by the FDA and more than 40% of the applications were discontinued during the study period. Safety discontinuations constituted a small, but significant, percentage of the discontinuations. Other reasons for discontinuation included product obsolescence and financial reasons. Drug discontinuations pose significant implications for research, product development, and determining societal needs for innovative pharmaceutical products.