MannKind: FDA Panel Meeting Tentatively Scheduled On April 1 For AFREZZA NDA

(RTTNews) - MannKind Corp. (MNKD) announced Friday that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration or FDA is tentatively scheduled on April 1, 2014 to review the company's New Drug Application or NDA for AFREZZA (insulin human [rDNA origin]) Inhalation Powder. The date and details of the meeting are subject to confirmation by the FDA in a Federal Register notice.

The company said it resubmitted the NDA on October 13, 2013 seeking approval to market AFREZZA in the United States with an indication to improve glycemic control in adults with type 1 or type 2 diabetes. The target date for the FDA to complete its review of the AFREZZA NDA is April 15, 2014.