FDA Acknowledges MannKind Resubmission of NDA for AFREZZA
MannKind Corporation (NASDAQ: MNKD) today announced that the U.S.
Food and Drug Administration (FDA) has acknowledged the resubmission of
a New Drug Application (NDA) for AFREZZA® (insulin human
[rDNA origin]) Inhalation Powder. The FDA considered the updated NDA to
be a complete class 2 response to its Complete Response Letter issued in
January 2011 and assigned a user fee goal date of April 15, 2014.
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the discovery,
development and commercialization of therapeutic products for patients
with diseases such as diabetes. Its lead product candidate, AFREZZA®,
has completed Phase 3 clinical trials. MannKind maintains a website at www.mannkindcorp.com