Gerresheimer's Lasix ONYU Receives Tentative FDA Approval

Gerresheimer AG has announced that the US Food and Drug Administration (FDA) has tentatively approved SQ Innovation's Lasix ONYU for the treatment of fluid overload in congestive heart failure patients. Combining a high-concentration furosemide formulation with Gerresheimer's on-body delivery device, Lasix ONYU promises home treatment capabilities. Although it meets US regulatory standards for quality, safety, and efficacy, full approval awaits expiration of a competing product's market exclusivity until October 2025.

The device, leveraging Gerresheimer's patented micropump technology, provides precise, comfortable drug administration. Its two-component system includes a reusable and a disposable unit, aligning with EcoDesign principles to minimize waste and costs. With potential for reduced healthcare costs and improved patient quality of life, Lasix ONYU is set to hit the market by the end of 2025.