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FDA accepts Fusilev response

November 30, 2010 12:13 AM UTC

FDA accepted for review a response from Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) to last year's complete response letter for an sNDA for Fusilev levoleucovorin injection to treat advanced metastatic colorectal cancer (mCRC). FDA designated the response as a Class 2 resubmission and set a PDUFA date of April 29, 2011. In its complete response letter, FDA had suggested that the company's sNDA did not demonstrate Fusilev's non-inferiority to leucovorin. ...