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FDA Agrees to Review Insulin Inhalation Powder, Afrezza
Approval decision slated for April 2014 (October 30)
The FDA has acknowledged the resubmission of a New Drug Application (NDA) for Afrezza (insulin human [rDNA origin]) inhalation powder (Mannkind Corporation).
The agency considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in January 2011. The user fee goal date is April 15, 2014.
Afrezza is a rapid-acting mealtime insulin therapy in late-stage clinical investigation for the treatment of adult patients with type-1 and type-2 diabetes mellitus for the control of hyperglycemia. It is a drug–device combination product, consisting of Afrezza inhalation powder (pre-metered into single-use cartridges) and the Afrezza inhaler.
Source: Mannkind Corp.; October 30, 2013.