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Ruling on new diabetes treatment delayed

By Jason Millman - 12/28/10 10:39 AM ET

Federal regulators need another four weeks to review an inhaled insulin product to treat diabetes, the drug's manufacturer announced Tuesday morning.

MannKind Corp. is awaiting a Food and Drug Administration ruling on Afrezza, which would be the first-ever inhalable insulin drug.The inhaler device, which delivers insulin through single-dose cartridges, was rejected by the FDA in March, when the agency requested more information from MannKind.

According to the company, the FDA informed it on Monday night that more time is needed to review the company's new drug application. The company had been expecting a decision sometime this week.


Source:
http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/135243-ruling-on-new-diabetes-treatment-delayed
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