BioCentury
ARTICLE | Company News

MannKind resubmits Afrezza NDA

October 14, 2013 11:41 PM UTC

MannKind Corp. (NASDAQ:MNKD) resubmitted an NDA to FDA for Afrezza to improve glycemic control in Type I and II diabetics. The resubmission 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 resubmission does not require a user fee, and MannKind said it does not expect the government shutdown to affect the PDUFA timing for Afrezza. FDA has said it would continue to accept submissions that do not require fees during the shutdown (see BioCentury Extra, Oct. 4). ...