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FDA Accepts Afrezza Submission

MannKind tries again with inhaled insulin

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The FDA has acknowledged the resubmission of an NDA by MannKind Corp. for Afrezza (insulin human [rDNA origin]) Inhalation Powder. The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in January 2011 and assigned a user fee goal date of April 15, 2014.

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