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13 Jan 2014

MannKind Announces Tentative Date of FDA Advisory Committee Review of AFREZZA

MannKind Corporation has announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is tentatively scheduled on 1 April 2014 to review MannKind's New Drug Application (NDA) for AFREZZA (insulin human [rDNA origin]) Inhalation Powder.


The date and details of the meeting are subject to confirmation by FDA in a Federal Register notice. MannKind resubmitted the NDA on 13 October 2013 seeking approval to market AFREZZA in the US 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 15 April 2014.

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