MannKind's inhaled insulin product faces US delay
This article was originally published in Scrip
Executive Summary
The US FDA has told MannKind that it will miss the January 16th user fee date for the NDA of its inhaled rapid-acting insulin product Afrezza (formerly Afresa). The drug is awaiting a decision for the treatment of adults with types 1 and 2 diabetes for the control of hyperglycaemia.