FDA approves sNDA for Furoscix (furosemide-subcutaneous) to expand the indication to include treatment of edema in patients with chronic kidney disease – sc Pharma

scPharmaceuticals Inc., announced that the FDA has approved the supplemental New Drug Application (sNDA) for Furoscix to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD).

“We are thrilled to announce that the FDA has approved the sNDA for Furoscix, expanding the indication to include the treatment of edema in patients with chronic kidney disease. This milestone marks a significant step forward for the Furoscix anchise and underscores our commitment to addressing unmet needs of cardiorenal patients,” said John Tucker, Chief Executive Officer of scPharmaceuticals. “In anticipation of this approval, we have taken strategic steps to ensure a successful launch, including key opinion leader engagement, comprehensive market research, and commercial readiness initiatives. We are excited to introduce Furosix to nephrologists and are focused on providing treatment options to both heart failure and CKD patients experiencing acute fluid overload.”

“Expanding the Furoscix indication to include patients with chronic kidney disease will provide a much-needed additional tool for clinicians to utilize in our management of fluid overload,” stated Suneel Udani, consulting physician at Nephrology Associates of Northern Illinois and Indiana (NANI). “Utilizing Furoscix can potentially help us keep our patients with heart failure and/or CKD at home while we restore and maintain euvolemia.”