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New NDA covers glycemic control in Types 1 and 2 diabetes
October 14, 2013
By: Gil Roth
President, Pharma & Biopharma Outsourcing Association
MannKind Corp. has resubmitted the NDA for Afrezza (insulin human [rDNA origin]) Inhalation Powder to the FDA. The NDA seeks approval for the marketing and sale of Afrezza with an indication to improve glycemic control in adults with type 1 or type 2 diabetes. The resubmission is based on the entire data set from the Afrezza clinical development program and particularly the positive results from two recent Phase III trials, one in patients with type 1 diabetes (study 171) and one in patients wi...
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