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MNKD > SEC Filings for MNKD > Form 8-K on 2-Apr-2014All Recent SEC Filings

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Other Events, Financial Statements and Exhibits

Item 8.01. Other Events.

On April 1, 2014, we announced that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDA) voted 13 to 1 to recommend that AFREZZA® (insulin human [rDNA origin]) Inhalation Powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes and voted 14 to 0 to recommend that AFREZZA be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes.

Although the EMDA provides recommendations to the FDA, the FDA makes the final decision with respect to approval of a drug. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of April 15, 2014 for its review of our New Drug Application (NDA) for AFREZZA®.

A copy of the press release 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 April 1, 2014, announcing FDA
        Advisory Committee's recommendation to approve MannKind's Investigational
        Drug to Treat Diabetes

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