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MannKind Corporation (MNKD) Announces FDA Acknowledgement of Resubmission of New Drug Application for AFREZZA


10/30/2013 7:39:42 AM

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VALENCIA, Calif.--(BUSINESS WIRE)--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.

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