Elite Pharmaceuticals Inc (ELTP)

[mrwrn2010]

Elite Pharmaceuticals Reports Positive Results from a Pivotal Bioequivalence Study

NORTHVALE, NJ / ACCESSWIRE / August 28, 2023 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company")(OTCQB:ELTP), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today reported positive results from pivotal fed and fasted bioequivalence studies for an undisclosed generic drug product in a class of medications called CNS stimulants. IQVIA reported annual sales for the twelve months ending June 2023 of $5.1 billion for the brand and generic market for this product.

The studies were open-label, randomized, balanced, single oral dose, two-treatment, two-period, two sequence, two-way crossover comparative bioavailability studies in healthy, adult, human subjects under fed and 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. ...