USFDAJul 24, 2026, 06:32 AM
MannKind Receives FDA Approval for Furoscix ReadyFlow
AI Summary
MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has approved Furoscix ReadyFlow™ (furosemide injection) for the treatment of edema in adults with heart failure or chronic kidney disease. This at-home autoinjector delivers an 80 mg/mL furosemide dose in under 10 seconds, providing an IV-equivalent diuretic effect. The approval marks a significant milestone, offering an earlier intervention option to manage fluid overload outside of hospital settings. Furoscix ReadyFlow is expected to be commercially available in the United States by the end of August 2026.
Key Highlights
- FDA approved Furoscix ReadyFlow for edema in adults with heart failure or chronic kidney disease.
- Furoscix ReadyFlow is an at-home autoinjector delivering 80 mg/mL furosemide dose.
- Administration takes under 10 seconds, offering IV-equivalent diuretic effect.
- Symptom relief may begin in an hour or less.
- The product is expected to be commercially available in the US by end of August 2026.
- Heart failure affects approximately 6.7 million adults in the US, projected to exceed 8 million by 2030.
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