ARTICLE | Company News
FDA committee to discuss MannKind's Afrezza
January 11, 2014 2:37 AM UTC
MannKind Corp. (NASDAQ:MNKD) said FDA set a tentative date of April 1 for a meeting of its Endocrinologic and Metabolic Drugs Advisory Committee to discuss a resubmitted NDA for Afrezza to improve glycemic control in Type I and II diabetics. The PDUFA date is April 15. In October, MannKind said FDA accepted for review the resubmitted NDA, which included 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. ...