FDA

FDA OK’s diuretic drug-device combo

October 17, 2025

Brand name: Lasix ONYU

Generic name: furosemide injection

Manufacturer: SQ Innovation, Inc.

Approval date: October 8, 2025

FDA approved the drug-device combination Lasix ONYU (furosemide injection) for the treatment of edema in adults with chronic heart failure.

According to a manufacturer press release, Lasix ONYU consists of a novel high-concentration formulation of furosemide combined with a small Infusor for treatment at home. The design includes a reusable unit that can be used for 48 treatments and a plastic sterile single-use unit that’s discarded after treatment.

Efficacy

Bioavailability and diuretic response were determined in two phase 1 studies (NCT04846816, NCT04384653) in which Lasix ONYU demonstrated complete bioavailability (112%) resulting in similar diuresis (115%) and natriuresis (117%) relative to the same dose given by IV bolus.

Safety

The most common adverse reactions reported during treatment with the Lasix ONYU Infusor were administration site and skin reactions: erythema, bruising, edema, and infusion site pain.

Sources:

SQ Innovation announces FDA approval of Lasix® ONYU for treatment of edema in heart failure. [News release]. 2025. https://sqinnovation.com/fda-approval/

Lasix ONYU (furosemide injection) [package insert]. SQ Innovation, Inc. https://www.lasix-onyu.com/wp-content/uploads/2025/10/prescribing-information.pdf Revised October 2025. Accessed October 16, 2025.

Osmanska J, et al. (2023, October 6). Eur Heart J Cardiovasc Pharmacother. A novel, small-volume subcutaneous furosemide formulation delivered by an abdominal patch infusor device in patients with heart failure: results of two phase I studies. https://pubmed.ncbi.nlm.nih.gov/37804170/