FDA nod for scPharmaceuticals’ Furoscix sNDA
Cardiorenal specialist scPharmaceuticals (Nasdaq: SCPH) has won US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Furoscix (furosemide injection) to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD).
It is already indicated for the treatment of edema in adult patients with chronic heart failure and will be available in the new CKD setting from next month, according to the company.
John Tucker, chief executive of scPharmaceuticals, said: “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 CKD. This milestone marks a significant step forward for the Furoscix franchise and underscores our commitment to addressing unmet needs of cardiorenal patients.
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