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FDA Accepts AFREZZA Resubmission and Sets Decision by Dec. 29, 2010

MannKind Corporation announced that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted, MannKind’s resubmission of its New Drug Application (NDA) for AFREZZA™ (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set an action date …

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