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MNKD > SEC Filings for MNKD > Form 8-K on 16-Oct-2013All Recent SEC Filings

Show all filings for MANNKIND CORP

Form 8-K for MANNKIND CORP


16-Oct-2013

Other Events, Financial Statements and Exhibits


Item 8.01 Other Events.

On October 14, 2013, we 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).

On October 14, 2013 we issued a press release announcing the resubmission of the NDA to the FDA, a copy of which is attached as Exhibit 99.1 to this current report.



Item 9.01 Financial Statements and Exhibits.

(d) Exhibits. The following exhibits are filed herewith:

99.1 Press Release of MannKind Corporation dated October 14, 2013, reporting MannKind's resubmission of the NDA to the FDA seeking approval of AFREZZA.


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