FDA accepts Mannkind’s response, sets PDUFA date

The FDA has accepted MannKind's resubmission of its NDA for the inhaled insulin drug Afrezza and set a PDUFA action date of December 29, 2010. The much-watched Afrezza NDA received a complete response letter from the FDA in March. At that time the agency requested more information related to several areas of the NDA, including updated safety data related and additional clinical data that support the clinical utility of Afrezza. Regulators also wanted data about the device Mannkind...