MannKind Corporation has again received a complete response letter from the FDA in regards to its application for Afrezza inhaled insulin. A previous CRL was issued in March 2010, and the company resubmitted the NDA in July of that year. The FDA is now asking for additional clinical trials using the next-generation delivery device for the product and for additional safety data. Read the company’s press release.
Another CRL for Afrezza
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