FDA approves expanded indication of furosemide injection for NYHA class IV heart failure
Key takeaways:
- The FDA approved an expanded indication of self-administered subcutaneous furosemide for patients with HF.
- The expanded indication now includes patients with NYHA class IV chronic HF.
scPharmaceuticals Inc. announced the FDA approved the supplemental new drug application to expand the indication of its self-administered subcutaneous furosemide injection for patients with heart failure.
As Healio previously reported, the FDA approved the company’s furosemide injection (Furoscix) for the treatment of congestion from fluid overload in adults with NYHA class II and III chronic HF in 2022.
The new indication now includes patients with NYHA Class IV chronic HF, according to a company press release.
“FDA approval of our [supplemental] NDA 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,” John Tucker, CEO of scPharmaceuticals, said in the release.
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