FDA Says “Maybe Later” to Inhaled Insulin

FDA Says “Maybe Later” to Inhaled Insulin: MannKind’s whistle-sized inhaled insulin device, Afrezza, was designed to administer mealtime doses of powdered insulin in metered, single-use cartridges but ran into problems with the FDA over a redesign. FDA has asked for a new trial in Type 1 diabetes patients and another in Type 2 patients. The agency also asked for additional information on the device’s performance characteristics, usage, handling, shipment, and storage as well as updated information on safety, proposed user training, and changes to the proposed labeling.