美国食品和药物管理局批准了Furoscix ReadyFlow的sNDA,这是一种快速起作用的家庭使用的素胺自注射器,用于治疗心脏或脏疾病患者的胀. FDA accepted sNDA for Furoscix ReadyFlow, a fast-acting, home-use furosemide autoinjector for edema in heart or kidney disease patients.

美国食品和药物管理局已批准曼凯德公司的SNDA,用于Furoscix ReadyFlow,一种皮下化胺自注射剂,用于治疗慢性心力衰竭或病的成年人的. The FDA has accepted MannKind Corporation’s sNDA for Furoscix ReadyFlow, a subcutaneous furosemide autoinjector for treating edema in adults with chronic heart failure or kidney disease. 该装置在10秒以内提供80毫克/毫升剂量,第1阶段的研究显示,21个健康成人的生物等效度相当于四氟呋喃。 The device delivers an 80mg/mL dose in under 10 seconds, with a phase 1 study showing bioequivalence to IV furosemide in 21 healthy adults. 尿液和电解排泄液与IV结果吻合,治疗效果良好,尽量减少了疼痛。 Urine and electrolyte excretion matched IV results, and the treatment was well-tolerated with minimal pain. FDA的目标行动日期是2026年7月26日。 The FDA’s target action date is July 26, 2026. 如果获得批准,自动注射器可以更快地进行家庭治疗,减少住院和医疗费用。 If approved, the autoinjector could enable faster, home-based treatment, reducing hospitalizations and healthcare costs.