MannKind Corporation has announced that a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee for a review of the company’s NDA for Afrezza insulin inhalation powder has been scheduled tentatively for April 1, 2014.
The FDA set a PDUFA date of April 15, 2014 for Afrezza after MannKind resubmitted its NDA for the product in October 2013.
The company submitted its initial NDA for Afrezza in March 2009.
Read the MannKind press release.
