FDA approval of supplemental new drug application expanding the Furoscix (furosemide injection) indication in heart failure – sc Pharmaceuticals

scPharmaceuticals Inc. announced that the FDA has approved its Supplemental New Drug Application (sNDA) seeking to expand the Furoscix indication for heart failure patients.

At approval, Furoscix was only indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure. The new indication now includes patients with NYHA Class IV chronic heart failure who represent the most symptomatic patients and those with the greatest limitation on physical activity, comprising approximately 10% of all heart failure patients nationally.

“FDA approval of our sNDA represents a natural expansion of the Furoscix indication given its established efficacy and safety in treating congestion due to fluid overload in adult patients with chronic heart failure, offering the potential to prevent the need for heart failure-related hospital admission or readmission,” stated John Tucker, Chief Executive Officer of scPharmaceuticals. “The growing adoption of Furoscix among cardiologists and heart failure specialists, together with our other Furoscix life cycle management initiatives, has created a solid foundation from which we plan to drive sustained long-term growth.”

Furoscix (furosemide injection) 80 mg/10mL for subcutaneous use. Furoscix is indicated for the treatment of congestion due to fluid overload in adult patients with chronic heart failure.