FDA Approves At-Home Furoscix ReadyFlow Autoinjector

TUESDAY, July 28, 2026 (HealthDay News) — The U.S. Food and Drug Administration approved Furoscix ReadyFlow (furosemide injection; MannKind) for the treatment of edema in adults with heart failure or chronic kidney disease.

Furoscix ReadyFlow is an at-home treatment option administered as an autoinjector delivering subcutaneous furosemide with intravenous-equivalent exposure. Furoscix ReadyFlow provides a full 80-mg/mL dose in under 10 seconds, with symptom relief beginning in an hour or less.

The approval is based on trials showing that Furoscix ReadyFlow achieved its primary pharmacokinetic end point. Results also showed equivalent urine output, sodium excretion, and potassium excretion at six, eight, and 12 hours compared with intravenous furosemide. Furoscix ReadyFlow had a safety profile in line with known effects of oral and intravenous furosemide.

“Too often, patients living with heart failure or chronic kidney disease find themselves caught in a cycle of worsening fluid overload that can disrupt daily life and lead to emergency room visits and hospitalization,” Hunter Champion, M.D., Ph.D., from the Emory University Healthcare Network in Columbus, Georgia, said in a statement. “An at-home option … gives clinicians an important new tool to intervene as soon as signs and symptoms of fluid overload appear helping appropriate patients manage congestion outside the hospital setting while reducing the disruption and burden associated with hospital-based treatment.”

The approval of Furoscix ReadyFlow was granted to MannKind.

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