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FDA accepts Krystexxa BLA

March 31, 2010 1:30 AM UTC

FDA accepted for review the resubmission of a BLA for Krystexxa pegloticase from Savient Pharmaceuticals Inc. (NASDAQ:SVNT) to treat chronic refractory gout. The PDUFA date is Sept. 14. The resubmission includes data from manufacturing validation batches of the pegloticase active pharmaceutical ingredient (API) and other information requested in a July 2009 complete response letter (See BioCentury Extra, Monday, March 15, 2010). ...