Crush-resistant Opana ER oxymorphone regulatory update

Endo submitted 2 Citizen's Petitions to FDA asking the agency to require any ANDAs referencing pain drug Opana ER oxymorphone contain data and information demonstrating the generic is similarly crush-resistant as the reformulated Opana ER. Additionally, Endo asked the agency to determine that the non-crush resistant formulation of Opana ER was discontinued from sale for safety reasons when not taken as prescribed; classify the reformulated Opana ER as a new dosage in FDA's Orange Book; and confirm that any ANDA referencing the non-crush resistant Opana ER will not be identified in the Orange Book as therapeutically equivalent to the reformulated Opana ER. ...