Exalgo review extended

FDA extended by three months the PDUFA date for an NDA from Neuromed Pharmaceuticals Ltd. (Vancouver, B.C.) for Exalgo hydromorphone to manage moderate to severe pain in opioid-tolerant patients to Feb. 22 from Nov. 22. According to Neuromed and U.S. commercialization partner Covidien plc (NYSE:COV), FDA needed more time to complete the review. Neuromed had submitted supplemental information, which the agency considered to be a major amendment. On Monday, Neuromed said FDA had indicated that the NDA is "not sufficient" for approval in its current form (See BioCentury Extra, Monday, Nov. 16, 2009). ...