Full Press Release Details
Announces FDA Acknowledgement of Resubmission of New Drug Application
VALENCIA, Calif.--(BUSINESS WIRE)--October 30, 2013--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
to which MannKind regularly posts copies of its press releases as well
as additional information about MannKind. Interested persons can
subscribe on the MannKind website to e-mail alerts that are sent
automatically when MannKind issues press releases, files its reports
with the Securities and Exchange Commission or posts certain other
information to the website.
MannKind Corporation
MCS Healthcare Public Relations
Laura De Zutter or Jeff