BioCentury
ARTICLE | Company News

Endo, U.S. Food and Drug Administration neurology news

December 24, 2012 8:00 AM UTC

Endo said a judge in the U.S. District Court for the District of Columbia dismissed the company's suit seeking to force FDA to determine in "a timely fashion" if the company withdrew the original, non-crush resistant formulation of pain drug Opana ER oxymorphone due to safety reasons. FDA is required by law to withdraw or suspend approval of ANDA's for generic versions of drugs removed from the market for safety reasons. Endo withdrew the non-crush resistant formulation of Opana ER in May after FDA approved a crush-resistant formulation of the extended-release opioid analgesic last December. Endo said the decision allows generic versions of non-crush resistant Opana to enter the market on Jan. 2. The company said FDA expects to make a decision by May 2013. The company also said it was "extremely disappointed" by the decision. ...