In an article on December 3, 2012, Law360 reported that Venable client, Endo Pharmaceuticals Inc., filed a complaint and injunction with a Washington federal court, requesting that the U.S. Food and Drug Administration (FDA) issue a safety determination regarding Endo's original Opana ER drug.
Endo voluntarily recalled the original version of its Opana ER drug, claiming it was vulnerable to misuse and abuse by crushing and snorting the pills. Since the recall, Endo has unveiled a safer, crush-resistant version of the drug, but the FDA has yet to release a safety determination about the original version. Generic versions of Opana ER by Impax Pharmaceuticals Inc. and Actavis South Atlantic LLC are set for market release on January 1. Endo is urging the court to force the FDA to halt all generic versions of the drug until the agency makes a safety determination.
Endo is represented by partners Ralph Tyler and David Goewey, and associates Meredith Boylan and Michael Bracken.