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DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

MannKind Resubmits New Drug Application to U.S. FDA for AFREZZA for the Treatment of Adults with Diabetes

 NDA  Comments Off on MannKind Resubmits New Drug Application to U.S. FDA for AFREZZA for the Treatment of Adults with Diabetes
Oct 152013
 

VALENCIA, Calif., October 14, 2013 –(BUSINESS WIRE)–MannKind Corporation (Nasdaq: MNKD) today 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).

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