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# Furosemide Injection sNDA Faces Submission Delay
- URL: https://www.fdaweb.com/furosemide-injection-snda-faces-submission-delay/
- Published: 2024-12-11T12:00:00.000Z
- Updated: 2026-09-14T14:49:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158344

A planned supplemental NDA submission from scPharmaceuticals of an autoinjector as an alternative to the current on-body infusor used with its Furoscix (furosemide injection) combination product may be delayed due to recently observed variability during shelf-life testing in one lot of the investigational product, according to the company.

Furoscix was approved in 2022 for treating congestion due to fluid overload in adults with New York Heart Association Class 2/3 chronic heart failure. The company says Furoscix is the first FDA-approved subcutaneous loop diuretic that delivers intravenous-equivalent diuresis at home using an infusor. It notes that the product is not indicated for emergency situations or in patients with acute pulmonary edema.

In August, the company reported bioavailability, pharmacokinetic and pharmacodynamic data of the investigational autoinjector product administered as a subcutaneous 80mg injection compared with the equivalent dose of furosemide administered as two 40mg intravenous (IV) injections. It noted that the autoinjector demonstrated a bioavailability of 107.3%, which was in line with the targeted “90% confidence interval limit of 80 to 125%.” It also said that autoinjector participants had similar urine output, urinary sodium excretion and urinary potassium excretion compared to IV furosemide.