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
published on
Featured event:
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
October 28-October 30: Deutches Aerosol Therapie Symposium (DATS), Marburg, Germany
October 28, 2026: Webinar: From Guidance to Practice: Navigating Revised FDA PSGs for Inhaled Products, online
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
