Elite Pharmaceuticals Inc (ELTP)

[senderos]

Nov 02, 2022

Elite Pharmaceuticals Reports Positive Results from a Pivotal Bioequivalence Study


NORTHVALE, NJ / November 2, 2022 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, today reported positive results from pivotal fed and fasted bioequivalence studies for an undisclosed extended-release generic drug product in a class of medications called dopamine agonists. IQVIA reported annual revenue for the twelve months ending August 2022 of $12 million for the generic market for this product.

The studies were single-dose crossover comparative bioavailability studies in healthy male and female volunteers in both the fed and fasting states. 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.