FDA Needs More Time to Review MannKind’s New Drug Application for Inhaled Insulin

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MannKind Corp. announced that it was informed today by the Food and Drug Administration that they will not be able to complete the review of MannKind’s new drug application for its ultra rapid-acting insulin therapy by the action date of January 16, 2010.The FDA explained that it has not yet completed its inspection of the insulin manufacturing facilities of N.V. Organon, a third-party supplier to MannKind. Organon is a subsidiary of Merck Inc.

As part of the ongoing discussions between MannKind and the FDA, the agency has accepted AFREZZA(TM) (insulin human Inhalation Powder) as the trade name for the product, which was formerly known as AFRESA(R). The agency had requested that the name of the product be changed in order to avoid confusion with another medication. AFREZZA(TM) is an ultra rapid acting insulin product that has completed Phase 3 trials.

MannKind has not yet been informed about the expected timing for the agency’s final determination on the new drug application, which will be provided in an Action Letter.

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