SQ Innovation, Inc. today announced that following its FDA approval in October 2025, Lasix ONYU (furosemide injection) is now available for ordering through Cardinal Health's Specialty Pharmaceutical Distribution (SPD) and Cencora's Specialty Distribution (formerly AmerisourceBergen).
SQ Innovation also announced that it signed a Medicaid National Drug Rebate Agreement (NDRA) with CMS and that Lasix ONYU is available to 340B-eligible hospitals, medical facilities and pharmacies.
Lasix ONYU received FDA approval on October 7, 2025, for the treatment of edema (due to fluid overload) in adult patients with chronic heart failure. The product enables selected patients to receive treatment at home, as prescribed by a clinician, without the need for a healthcare professional to administer the drug.
Lasix ONYU is a drug-device combination that was approved by the U.S. Food and Drug Administration on October 7, 2025, for the treatment of edema in adult patients with chronic heart failure.
The pharmaceutical component of Lasix ONYU is a novel, high-concentration formulation of the diuretic furosemide, at 30 mg/mL. It comes in a pre-filled glass cartridge containing 80 mg of furosemide in 2.67 mL. The Lasix ONYU Infusor consists of two main parts: the Reusable Unit and the Disposable Unit.
The Reusable Unit is an electromechanical device that contains the battery, motor, and electronic components necessary for operation and safety functions. It can be used up to 48 times before it can be recycled.
The Disposable Unit is a sterile, single-use plastic component that holds the drug cartridge. It includes a micropiston pump, fluid path, needle insertion and retraction mechanism, and a 29-gauge needle.
After placement on the abdomen, the needle penetrates the skin when the device is activated. The Lasix ONYU Infusor slowly administers 80 mg furosemide over a period of five hours. This method results in significant diuresis similar to IV, but in a more controlled manner. This avoids the brief, intense diuretic effect that occurs with rapid IV infusion or injection. The advanced two component design offers benefits for patients, healthcare providers, payers, and the environment.
