Afrezza, Inhaled Insulin, NDA Resubmitted to FDA

MannKind Corp. announced the resubmission of a New Drug Application (NDA) to the FDA seeking approval for the marketing and sale of Afrezza (insulin human [rDNA origin]) Inhalation Powder to improve glycemic control in adults with type 1 or type 2 diabetes.

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The resubmission was 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).

Afrezza is a novel, ultra rapid-acting mealtime insulin therapy delivered using a small, discreet and easy-to-use inhaler.

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