FDA Informs Mannkind It Needs More Time to Review AFREZZA NDA

December 28, 2010

The FDA informed MannKind Corporation that it would not be able to complete the review of the New Drug Application (NDA) for AFREZZA (insulin human [rDNA origin]) Inhalation Powder by the action date of December 29, 2010. The FDA stated that it will require approximately four additional weeks to complete its review of the NDA.

AFREZZA is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with type 1 and type 2 diabetes. It is a combination product, consisting of AFREZZA Inhalation Powder pre-metered into single use dose cartridges and delivered via a small, discreet and easy-to-use AFREZZA Inhaler.

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