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Breaking News, Trials & Filings

Afrezza Gets Panel Date

Mannkind's inhaleable insulin to get committee review

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

MannKind Corp. has received word that the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is tentatively scheduled on April 1, 2014 to review the company’s NDA for Afrezza (insulin human [rDNA origin]) Inhalation Powder. The date and details of the meeting are subject to confirmation by the FDA in a Federal Register notice.
 
MannKind resubmitted the NDA on October 13, 2013 seeking approval to market Afrezza in the U.S. with an indication to improve glycemic control in adults with type 1 or type 2 diabetes. The target date for the FDA to complete its review of the NDA is April 15, 2014. The company initially filed Afrezza’s NDA in 2009, but the FDA requested additional clinical trials to support it.

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