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FDA confirms Afrezza committee date

February 22, 2014 1:46 AM UTC

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet April 1 to discuss a resubmitted NDA from MannKind Corp. (NASDAQ:MNKD) for Afrezza to improve glycemic control in Type I and II diabetics. The resubmitted NDA includes data from two additional trials that were requested by FDA in a 2011 complete response letter, the agency's second for the dry powder formulation of insulin plus an inhaler. The PDUFA date is April 15. ...