FDA Informs Mannkind It Needs More Time to Review AFREZZA NDA

December 28, 2010

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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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