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FDA needs more time to review
December 29, 2010
By: Tim Wright
Editor-in-Chief, Contract Pharma
The FDA has informed MannKind Corporation that the agency will not be able to complete the review of the 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 for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyper...
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