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# SQ Innovation Gets Edema At-Home Treatment OK’d
- URL: https://www.fdaweb.com/sq-innovation-gets-edema-at-home-treatment-okd/
- Published: 2025-10-10T12:00:00.000Z
- Updated: 2026-09-14T15:23:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160023

FDA has approved SQ Innovation’s drug-device combination Lasix ONYU (furosemide injection) for treating edema (due to fluid overload) in adult patients with chronic heart failure. The product was developed to enable subcutaneous infusion of furosemide outside the healthcare setting for selected patients, according to the company.

Lasix ONYU comprises a novel high-concentration formulation of furosemide combined with a small infusor for treatment at home. “The innovative design includes a reusable unit that can be used for 48 treatments and a plastic sterile single-use unit that is discarded after treatment," the company says.

SQ Innovation says approval was based on bioavailability and diuretic response data in which Lasix ONYU demonstrated complete bioavailability (112%) resulting in similar diuresis (115%) and natriuresis (117%) when compared to the same dose given by IV bolus. “The biphasic delivery of furosemide by the Infusor resulted in a tempered diuretic response while IV bolus administration led to a shorter period of more intense diuresis,” it says.