Core Viewpoint - MannKind Corporation has announced that the FDA has accepted the supplemental New Drug Application (sNDA) for the FUROSCIX ReadyFlow™ Autoinjector, which aims to provide a subcutaneous furosemide injection in under 10 seconds for patients with chronic heart failure (CHF) or chronic kidney disease (CKD) [1][2] Group 1: Product Development and Approval - The FUROSCIX ReadyFlow Autoinjector is designed to deliver treatment in under 10 seconds, potentially transforming the management of fluid buildup in adults with CHF or CKD, thereby reducing hospital admissions and overall healthcare costs [2][8] - The sNDA has a Prescription Drug User Fee Act (PDUFA) target action date set for July 26, 2026 [1][8] - If approved, the ReadyFlow Autoinjector would allow patients to manage fluid buildup episodes at home, contrasting with the existing FUROSCIX On-body Infusor, which requires a five-hour administration time [2][8] Group 2: Clinical Study Results - Positive study results from August 2024 support the sNDA, showing that furosemide via the ReadyFlow Autoinjector achieved a bioavailability of 107.3% within the 90% confidence interval limit of 80 to 125 percent [3] - Participants using the ReadyFlow Autoinjector exhibited similar urine output and urinary excretion metrics compared to intravenous furosemide, indicating comparable efficacy [3] - The study involved 21 healthy volunteers aged 45 to 80 and utilized a randomized, two-way crossover design [4]