Elite Pharmaceuticals reports results from bioequivalence study

Elite Pharmaceuticals reported results from pivotal fasted bioequivalence studies for an undisclosed generic drug product in a class of medications called antimetabolites . IQVIA reported annual sales for the twelve months ending December 2022 of $42 million for the generic market for this product. The studies were open label, single-dose crossover comparative bioavailability studies in volunteers of male and female patients who were already on established drug regimens under fasting conditions. The results indicate that the generic product is bioequivalent to the branded product. Elite is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and Drug Administration.