MannKind, which resubmitted its NDA for Afrezza inhaled insulin earlier this month, has announced that, “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.”
The FDA goal is to “Review and act on 90 percent of Class 2 resubmitted original applications within 6 months of receipt.”
Read the MannKind press release.
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