MannKind Corporation MNKD today announced the
resubmission on October 13, 2013 of a new drug application (NDA) to the
U.S. Food and Drug Administration (FDA) seeking approval for the
marketing and sale of AFREZZA® (insulin human [rDNA origin])
Inhalation Powder with an indication to improve glycemic control in
adults with type 1 or type 2 diabetes. The resubmission is based on the
entire data set from the extensive AFREZZA clinical development program
and particularly the positive results from two recent Phase 3 trials,
one in patients with type 1 diabetes (study 171) and one in patients
with type 2 diabetes (study 175).
“We designed the recent studies with input and guidance from the FDA,
See full press release
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