OBJECTIVES:  It has been suggested that some recent price increases of older generic medications may be attributed to the FDA Unapproved Drugs Initiative (UDI), a program to improve safety by removing unapproved drugs from the market. Colchicine is a good example of a previously unapproved drug marketed for many years at a low price. In 2009, a New Drug Application (NDA) was approved for colchicine (Colcrys) in accordance with FDA’s UDI, and in 2015 a FDA approved branded generic became available. This study assessed the impact of FDA’s UDI on expenditures for oral colchicine before and after the NDA by conducting a descriptive analysis of expenditures over time. METHODS: Data on drug expenditures, adjusted for inflation using the Consumer Price Index, and units sold from January 1, 2006 to December 31, 2015 were obtained from the IMS Health National Sales Perspective database. Expenditures (in 2015 $), units sold, and expenditures/unit (“price”) by year were plotted graphically to observe trends over time. Percentage change of each over time was also examined. RESULTS: The most volatile time period observed was 2010 to 2014, during which there was a 437% increase in total expenditures, a 574% increase in total expenditures/unit, and a 20% decline in total units sold (total = unapproved and approved products). During the same period, Colcrys expenditures and units sold exhibited a 1,096% and 941% increase respectively. Meanwhile, unapproved oral colchicine expenditures and units sold declined 100% to zero in 2014 due to market exit prompted by FDA’s UDI. Subsequently, in 2015, the branded generic oral colchicine entered the market, which lead to a decline of approximately 60% in expenditures and units sold for Colcrys. CONCLUSIONS:  Expenditures for oral colchicine rose substantially following FDA approval, driven largely by increased price, suggesting a substantial market impact of FDA’s UDI on expenditures.