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news.The US Food & Drug Administration (FDA) has delayed the review of MannKind's new drug application (NDA) for Afrezza (insulin human [rDNA origin]) Inhalation Powder by the action date of 29 December 2010.
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MannKind claims that 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 for the control of hyperglycemia.
The FDA stated that it will require approximately four additional weeks to complete its review of the NDA.
MannKind discovers, develops and commercializes therapeutic products for patients with diseases such as diabetes and cancer.