Posted by Michael Wonder on 02 Dec 2025
MannKind announces US FDA accepts for review its supplemental new drug application of Furoscix ReadyFlow Auto-injector for the treatment of oedema in adults with chronic heart failure or chronic kidney disease
1 December 2025 - MannKind Corporation today announced that the US FDA has accepted the sNDA seeking approval for Furoscix ReadyFlow Auto-injector (SCP-111), developed to deliver a subcutaneous furosemide injection in under 10 seconds as an investigational alternative to the FDA-approved Furoscix (furosemide) on-body infusor for treatment of oedema in adult patients with chronic heart failure or chronic kidney disease.
The application has been assigned a PDUFA target action date of 26 July 2026.
