MannKind Corp., MNKD, FDA Calendar, PDUFA Date

Company Name	MannKind Corp. MNKD
Drug Name	FUROSCIX ReadyFlow Autoinjector (sNDA)
Event Name	FDA decision on FUROSCIX ReadyFlow Autoinjector for the Treatment of Edema in adults with Chronic Heart Failure or Chronic Kidney Disease
Event Date	07/26/2026
Outcome Date
Outcome	Pending
Drug Status	If approved, FUROSCIX ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds
Rival Drugs
Market Potential
Other Approvals	On October 10, 2022, the FDA approved Furoscix (furosemide injection) for the at-home treatment of congestion due to fluid overload in chronic heart failure. This was followed on August 12, 2024, by FDA approval of a supplemental new drug application expanding the indication to include treatment in heart failure. Most recently, on March 7, 2025, the FDA approved another supplemental new drug application further expanding the indication to include the treatment of edema in patients with chronic kidney disease.
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