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Exalgo review extended

November 21, 2009 1:31 AM UTC

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). ...