FDA Acknowledges MannKind's Resubmission Of AFREZZA NDA - Quick Facts

(RTTNews) - MannKind Corp.(MNKD), Wednesday said the U.S. Food and Drug Administration or FDA has accepted the resubmission of a New Drug Application for AFREZZA Inhalation Powder. The FDA acknowledged 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.

MannKind 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.