MannKind Corporation said the U.S. Food & Drug Administration has accepted its resubmitted application for Afreeza, an ultra-quick acting, inhalable form of insulin, according to a recent article from DLife.
Earlier this year the regulator asked Mannkind for additional information and the company responded by submitting clinical data on the effectiveness of the drug on Type 1 diabetics from a study. It also submitted additional safety data. (See MannKind Touts Effectiveness, Safety of New Inhalable Insulin)
The company expects to hear from the regulator by the end of the year on the new application.
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