BioCentury
ARTICLE | Politics & Policy

FDA to respond to Endo petition

March 13, 2013 12:36 AM UTC

FDA said it will respond by May 10 to an August 2012 Citizen's Petition from Endo Health Solutions Inc. (NASDAQ:ENDP)asking the agency to determine that the non-crush resistant formulation of pain drug Opana ER oxymorphone had been discontinued from sale for safety reasons and thus can no longer serve as a reference listed drug. In January, FDA denied a separate Citizen's Petition from Endo asking the agency to require any ANDAs referencing Opana ER to show the generic is similarly crush-resistant. Endo was down $0.09 to $30.70 on Tuesday. ...