USFDA Grants Tentative Approval for Lasix ONYU in Heart Failure Treatment

Gerresheimer, a creative systems and solutions provider and a worldwide partner for the pharmaceutical, biotech, and cosmetics sectors, has announced that the US Food and Drug Administration (FDA) has granted SQ Innovation Tentative Approval for Lasix ONYU to treat fluid overload at home in patients with congestive heart failure. Lasix ONYU is a combined product featuring an innovative high-concentration formulation of the diuretic furosemide along with the Gerresheimer on-body medication delivery system.

Tentative Approval signifies that Lasix ONYU has fulfilled the regulatory criteria for quality, safety, and effectiveness necessary for approval in the United States. Complete approval was prevented since the FDA had awarded market exclusivity in the USA for a rival product until October 2025. SQ Innovation aims to pursue complete approval in the US once the regulatory exclusivity period concludes. The initial products from Lasix ONYU are anticipated to be launched in the market by the conclusion of 2025. The provisional approval of the combination product highlights Gerresheimer's innovation capability and the market preparedness of the Gerresheimer on-body drug delivery system.

“The FDA’s Tentative Approval is a testament to our product and the people and partners who have contributed to this great endeavour, especially the Gerresheimer team”, says Pieter Muntendam, MD, founder, president and CEO of SQ Innovation. “It is an important milestone. We look forward to commercializing this highly innovative combination product as soon as we receive final approval with the aim to improve patients' quality of life and reduce healthcare costs for the elderly.”